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2. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses
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Terrazas-Obregón, Carmen Sara, Terrones-Levano, Victor Francisco, Ticona-Huaroto, Cesar Eduardo, Torres-Ninapayta, Walter, Torres-Ruiz, Oscar Martin, Ugarte-Mercado, Dario, Vargas-Anahua, Orlando José, Vàsquez-Becerra, Ruben Dario, Vàsquez-Cerro, José Gabriel, Villegas-Chiroque, Miguel, Williams, Anna Larson, Yauri-Lazo, Randi Mauricio, Abad, Cybele Lara, Andales-Bacolcol, Silverose Ann, Arcegono, Marlon, Arches, Jamie, Astudillo, Mary Grace, Aventura, Emily, Awing, Arlyn, Bala, Mishelle Vonnabie, Bello, Jia An, Blanco, Peter, Benedicto, Jubert, Buno, Susana, Cabrera, Justine, Cajulao, Thea Pamela, Caoili, Janice, Casiple-Amsua, Lina, Catambing, Victor, Chin, Inofel, Chua, Ma. Bernadette, Chua, Mitzi Marie, Climacosa, Fresthel Monica, David-Wang, Aileen, De los Reyes, Virginia, Europa, Gilly May, Fernandez, Lenora, Francisco, Jorge, Garcia, Gerard, Garcia, Jemelyn, Gler, Maria Tarcela, Isidro, Marie Grace Dawn, Javier, Rozelle Jade, Kwek, Marion, Lansang, Mary Ann, Lee, Aileen, Li, Kingbherly, Llanes, Mark Ramon Victor, Llorin, Ryan, Macadato, Omar Khayyam, Malundo, Anna Flor, Mercado, Maria Elizabeth, Mujeres, Mercedes, Nepomuceno, Marisse, Ngo-Sanchez, Katha, Orden, Mary Claire, Pablo-Villamor, Maria Philina, Paez, Ruel Dionisio, Palmes, Patricio, Panaligan, Marion, Quinivista-Yoon, Jenny Mae, Ramos, Mary Shiela Ariola, Ramos -Penalosa, Christine, Reyes, Sheila Marie, Roa, Kathryn, Roman, Arthur Dessi, Rosario, Minette Claire, Roxas, Evalyn, Santos, Lourdes Ella Gonzales, Soldevilla, Helmar, Solante, Rontgene, Suaco, Jane, Tagarda, Daisy, Tang, Issa Rufina, Te, Bob, Teo, Dennis, Tibayan, Christopher John, Villalobos, Ralph Elvi, Ymbong, Duane Richard, Zabat, Gelza Mae, Batkova, Stepanka, Cardoso, Orlando, Garrote, Ana-Raquel, Lino, Sara, Manata, Maria-José, Pinheiro, Helder, Póvoas, Diana, Ramirez, Freddy, Seixas, Diana, Naji, Assem, Al Gethamy, M Al, AL-Mulaify, Mohammed Sami, Al Maghraby, Reem, Alrajhi, A, Al Sharidi, Aynaa, Alotaibi, Naif, AlShaharani, F, Barry, Mazin, Ghonem, Leen, Khalel, Anas, Kharaba, Ayman Mohammed, Alabdan, Lulwah, AlAbdullah, Mohammed Sharaf, Al Shabib, Abdullah, Bengu, Simangele, Bennet, Jacklyn, Dubula, Thozama, Howell, Pauline, Janse van Vuuren, Cloete, Kalla, Ismail, Lifson, Aimee, Maasdorp, Shaun, Magua, Nombulelo, Maluleke, Vongani, Mbhele, Nokuphiwa, Mdladla, Nathi, Mendelson, Mark, Menezes, Colin, Mwelase, Thando, Nchabeleng, Maphoshane, Palanee-Phillips, Thesla, Parker, Victoria, Rassool, Mohammed, Reeder, Paul, Sossen, Bianca, Steyn, Dewald, Tsitsi, Merika, van Blydenstein, Sarah Alex, Venter, Michelle, Van Vuuren, Janse, Venturas, Jacquie, Abad Pérez, Daniel, Abenza, Maria José, Alarcón-Payer, Carolina, Armero Garrigos, Eva, Arribas, Jose Ramon, Ascaso, Ana, Berenguer, Juan, Cabello-Clotet, Noemí, Chamorro Tojeiro, Sandra, Cuenca-Acevedo, Rafael, de la Calle, Fernando, Del Toro, Maria Dolores, Díaz Pollàn, Beatriz, Diez, Cristina, Esquillor-Rodrigo, María José, Estrada, Vicente, Fanciulli, Chiara, Fanjul, Francisco, Fernàndez de Orueta, Lucía, Ferre, Adrian, Ferreira Pasos, Eva Maria, Gainzarain-Arana, Juan-Carlos, Garcia, Felipe, García Deltoro, Miguel, Goikoetxea Agirre, Ane Josune, Gómez Barquero, Julia, Gomez-Huelgas, Ricardo, Gonzàlez Moraleja, Julio, Guijarro, Carlos, Gutierrez, Felix, Guzmàn, Jesús, Ibarguren, Maialen, Iribarren, Jose Antonio, Jerusalem, Koen, Juan Arribas, Arturo, Lalueza, A, Leone, Antonio, Lopez Azkarreta, Iñigo, Lozano-Martin, Daniel, Lucendo, Alfredo J, Luengo López, Mariella, Martín Oterino, JA, Masa, JF, Merino, Esperanza, Monge-Maillo, Begoña, Moran-Rodríguez, Miguel-Angel, Muñez Rubio, Elena, Muñoz Sanchez, Josefa, Nuñez Orantos, Maria Jose, Nuño, Enrique, Ortiz-De-Zarate-Ibarra, Zuriñe, Pagàn-Muñoz, Bàrbara, Paño-Pardo, José Ramón, Peñaranda, Maria, Pérez Chica, Gerardo, Pérez Fernàndez, AM, Pérez-López, Carmen, Polo San Ricardo, Victor, Portu-Zapirain, Joseba, Puchades, Francesco, Rivas Paterna, Ana Belen, Rodríguez Vidigal, Francisco F, Rodríguez-Baño, Jesus, Ruiz-Seco, Pilar, Ryan, Pablo, Saez-De-Adana, Ester, Salas, Rosario, Salavert Lletí, Miguel, Sandoval, Raquel, Toyas-Miazza, Carla, Valencia, Jorge, Vargas, Emilio, Velasco, Maria, Von Wichmann, Miguel Angel, Bosshard, Andreas, Calmy, Alexandra, Castro, Tiago, Cavassini, Matthias, Clerc, Olivier, Conen, Anna, Desbaillets, Nicolas, Desgranges, Florian, Duss, Francois, Emonet, Stephane, Erard, Veronique, Eyer, Myriam, Fayet-Mello, Aurélie, Flammer, Yvonne, Friedl, Andrée, Fulchini, Rosamaria, Furrer, Hansjakob, Garin, Nicolas, Gastberger, Salome, Greiner, Michael, Haefliger, David, Haubitz, Sebastian, Hoffmann, Matthias, Isenring, Egon, Jakopp, Barbara, Lampert, Markus, Marinosci, Annalisa, Martin, Yvonne, Petignat, Pierre-Auguste, Piso, Rein Jan, Prendki, Virginie, Rutishauser, Jonas, Schaefer, Elisabeth, Schmiedel, Yvonne, Schwery, Stefan, Stavropoulou, Elisavet, Stoeckle, Marcel, Suttels, Veronique, Thurnher, Maria Christine, van den Bogaart, Lorena, West, Emily, Wiegand, Jan, and Wiggli, Benedikt
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3. Outcomes with Finerenone in Participants with Stage 4 CKD and Type 2 Diabetes: A FIDELITY Subgroup Analysis
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Sarafidis, Pantelis, Agarwal, Rajiv, Pitt, Bertram, Wanner, Christoph, Filippatos, Gerasimos, Boletis, John, Tuttle, Katherine R., Ruilope, Luis M., Rossing, Peter, Toto, Robert, Anker, Stefan D., Liu, Zhi-Hong, Joseph, Amer, Ahlers, Christiane, Brinker, Meike, Lawatscheck, Robert, Bakris, George, Aizenberg, Diego, Bartolacci, Inés, Besada, Diego, Bittar, Julio, Chahin, Mariano, Elbert, Alicia, Gelersztein, Elizabeth, Liberman, Alberto, Maffei, Laura, Manghi, Federico Pérez, Sanabria, Hugo, Vallejos, Augusto, Viñes, Gloria, Wassermann, Alfredo, Abhayaratna, Walter, Acharya, Shamasunder, Ekinci, Elif, Lee, Darren, MacIsaac, Richard, Mah, Peak Mann, Nelson, Craig, Packham, David, Pape, Alexia, Roger, Simon, Stephenson, Hugo, Suranyi, Michael, Wittert, Gary, Vale, Elizabeth, Colman, Peter, Colquhoun, David, Ellis, Chris, Joshua, Kim, Pedagogos, Eugenia, Regal, Paul, Topliss, Duncan, Vandeleur, James, Verjans, Johan, Wittert, Gary, Wynne, Katie-Jane, Clodi, Martin, Ebenbichler, Christoph, 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Sydney, Yanay, Noa Berar, Chernin, Gil, Darawsha, Mahmud, Efrati, Shai, Elias, Mazen, Farber, Evgeny, Glandt, Mariela, Grossman, Ehud, Halabi, Majdi, Harman-Boehm, Ilana, Khazim, Khaled, Liberty, Idit, Minuchin, Oscar, Mosenzon, Ofri, Nakhoul, Farid, Nimer, Assy, Schwartz, Doron, Wainstein, Julio, Yagil, Yoram, Zukermann, Robert, Avogaro, Angelo, Battaglia, Giovanni Giorgio, Bevilacqua, Maurizio Tiziano, Bonora, Enzo, Bossi, Carlo Antonio, Calabrò, Paolo, Cavalot, Franco Luigi, Cimino, Roberto, Cozzolino, Mario Gennaro, David, Salvatore, Emdin, Michele, Fiaccadori, Enrico, Fiorina, Paolo, Giorda, Carlo Bruno, Gregorini, Maria Cristina, La Manna, Gaetano, Maggi, Davide Carlo, Manti, Roberta, Meregalli, Giancarla, Pani, Antonello, Parvanova, Aneliy Ilieva, Perico, Norberto, Piatti, PierMarco, Pisani, Antonio, Pontiroli, Antonio Ettore, Ponzani, Paola, Santorelli, Gennaro, Santoro, Domenico, Scanziani, Renzo, Teatini, Ugo, Tonolo, Giancarlo, Trevisan, Roberto, Veronelli, Anna Maria, 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Lars, Gregoor, Peter Smak, Vogt, Liffert, Born, Bert-Jan van den, John Baker, Crawford, Veronica, Cutfield, Rick, Dunn, Peter, Krebs, Jeremy, Nirmalaraj, Kingsley, Scott, Russell, Smuts, Nine, Titchener, Janet, Eriksen, Erik, Finnes, Trine, Høivik, Hans, Karlsson, Thomas, Munk, Peter Scott, Radtke, Maria, Risberg, Knut, Rocke, Jan, Solnør, Leidulv, Stenehjem, Aud-Eldrid, Tafjord, Anne-Beathe, Asprusten, Emil, Hagemeier, Robert, Høye, Kjetil, Selsås, Hilde, Thorup, Frode, Wium, Cecilie, Pamugas, Glenda, Panelo, Araceli, Perez, Ronald, Tanque, Maribel, Tirador, Louie, Villa, Michael, Bautista, Albert, Catindig, Elizabeth, Manalo, Carlo, Mirasol, Roberto, Butrymowicz, Patrycja, Ciechanowski, Kazimierz, Cieslik, Grazyna, Franek, Edward, Gumprecht, Janusz, Hoffmann, Michal, Krzykowska, Jolanta, Kurnatowska, Ilona, Landa, Katarzyna, Madrzejewski, Adam, Madziarska, Katarzyna, Mazur, Stanislaw, Napora, Piotr, Nowicki, Michal, Ocicka-Kozakiewicz, Anna, Rewerska, Barbara, Rusicka, Teresa, Ruxer, Jan, Skokowska, Ewa, Stankiewicz, Andrzej, Stompor, Tomasz, Tiuryn-Petrulewicz, Agnieszka, Wasilewska, Katarzyna, Wierusz-Wysocka, Bogna, Wnetrzak-Michalska, Renata, Jedynasty, Krystyna, Anand, Izabela Sein, Almeida, Edgar, Ballesteros, Rosa, Barreto, Carlos, Beirao, Idalina, Birne, Rita, Esteves, Cesar, Guia, Jose, Heitor, Susana, Marques, Olinda, Melo, Pedro, Nolasco, Fernando, Pereira, Amalia, Roque, Cristina, Rosario, Francisco, Silva, Gil, Silva, Ana, Teixeira e Costa, Fernando, Lobos, Ana Vila, Alves, Ana Rita, Brandao, Ilidio, Carvalho, Rui, Coelho, Joao, Lourenco, Ana, Matos, Pedro, Rosario, Vanisa, Neves, Joao Sergio, Cortes-Maisonet, Gregorio, Roman-Miranda, Amaury, Brito-Peguero, Yudit, Colon-Vega, Gildred, Albota, Adrian, Bala, Cornelia, Barbonta, Hortensia, Caceaune, Elena, Catrinoui, Doina, Constantin, Ciprian, Dumitrescu, Adriana, Mindrescu, Nicoleta, Mistode, Cristina, Negrisanu, Gabriela, Onaca, Adriana, Paveliu, Silvia, Pintilei, Ella, Pop, Lavinia, Popa, Amorin, Popescu, Alexandrina, Radulian, Gabriela, Szilagyi, Iosif, Turcu, Liana, Vacaru, Georgeta, Vlad, Adrian, Filimon, Adriana, Veresiu, Ioan, Antsiferov, Mikhail, Arkhipov, Mikhail, Babkin, Andrey, Barbarash, Olga, Baranov, Vitaliy, Chernyavskaya, Elena, Demko, Arkadiy, Dreval, Alexander, Edin, Anton, Ermakova, Polina, Fadeev, Valentin, Galyavich, Albert, Gaysina, Leyla, Gordeev, Ivan, Ipatko, Irina, Kalashnikova, Marina, Khalimov, Yuriy, Klimontov, Vadim, Kobalava, Zhanna, Kosmacheva, Elena, Koziolova, Natalya, Sergey Levashov, Lyudmila Kvitkova, Libis, Roman, Marasaev, Vyacheslav, Malykh, Natalia, Martynenko, Vladimir, Malyutina, Sofya, Merai, Imad, Mkrtumyan, Ashot, Nechaeva, Galina, Petunina, Nina, Palyutin, Shamil, Pimenov, Leonid, Rechkova, Elena, Rodionova, Tatyana, Rymar, Oksana, Sardinov, Ruslan, Semenova, Olga, Sherenkov, Alexander, Solovev, Oleg, Smolyarchuk, Elena, Strongin, Leonid, Ukhanova, Olga, Verlan, Nadezhda, Vorokhobina, Natalya, Yakhontov, Davyd, Yakushin, Sergey, Zakharova, Elena, Zalevskaya, Alsu, Zanozina, Olga, Zhdanova, Elena, Zhukova, Larisa, Zykova, Tatyana, Argunova, Yulia, Nikolaev, Konstantin, Villevalde, Svetlana, Fang Sum, Chee, Suhail, Sufi Muhummad, San Tan, Ru, Vathsala, Anantharaman, Wong, Edmund, Bee, Yong Mong, Babikova, Jana, Buganova, Ingrid, Dzupina, Andrej, Ochodnicka, Zuzana, Sosovec, Dalibor, Spodniakova, Denisa, Minarik, Peter, Fayzal Ahmed, Amod, Aslam, Bhana, Sindeep, Distiller, Larry, Jansen van Rensburg, Dirkie, Joshi, Mukesh, Joshi, Shaifali, Lakha, Deepak, Mitha, Essack, Podgorski, Gracjan, Ranjith, Naresh, Rayner, Brian, Rheeder, Paul, Sarvan, Mohamed, Seeber, Mary, Siebert, Heidi, Tayob, Mohammed, Trokis, Julien, Urbach, Dorothea, van Zyl, Louis, Jansen van Rensburg, Dirkie, Bum-Soon Choi, Choi, Moon Gi, Chung, ChoonHee, Hwang, YouCheol, Kim, ChongHwa, Kim, InJoo, Kim, JaeHyeon, Kim, SinGon, Kim, SungGyun, Kim, Tae Hee, Lee, WooJe, Lee, ByungWan, Lee, Kang Wook, Oh, Kook-Hwan, Oh, Ji Eun, Oh, Yun Kyu, Oh, Dong-Jin, Park, Junbeom, Shin, Seok Joon, Sung, Su-Ah, Yu, Jae Myung, Chung, HyeSoo, Huh, Ji Hye, Kang, JunGoo, Kim, ChulSik, Kim, HyeSoon, Kim, NamHoon, Lim, Soo, Cho, Young Min, Park, Cheol Young, Agraz, Irene, Ampudia, Francisco Javier, Bouarich, Hanane, Calero, Francesca, Castro, Cristina, Guldris, Secundino Cigarrán, Garrit, Josep Cruzado, de Álvaro, Fernando, Galcerán, Josep, Albarrán, Olga González, Jaras, Julio Hernández, Ibernón, Meritxell, Deben, Francisco Martínez, Ma, Esteban, Dolores Martínez, Pascual Izuel, José María, Martins, Judith, Mediavilla, Juan, Michán, Alfredo, Santos, Julio Pascual, Poch, Esteban, Rusillo, Manuel Polaina, Juan, Carlos Sánchez, Olmo, Rafael Santamaría, Segura de la Morena, José Julián, Soto, Alfonso, Troya, Maribel, Castro, Fernando Cereto, Fernández, Pablo Gómez, Sánchez, Laura Fuentes, Moya, Mercedes González, Marrero, Domingo Hernández, Maroto, Gonzalo Piedrola, Redón, Josep, Seron, Daniel, Bruchfeld, Annette, Curiac, Dan, Eliasson, Ken, Frank, Malin, Guron, Gregor, Hellberg, Olof, Hellgren, Margareta, Larnefeldt, Hans, Lindholm, Carl-Johan, Löndahl, Magnus, Rein-Hedin, Erik, Soveri, Inga, Spaak, Jonas, Tengmark, Bengt-Olov, Lif-Tiberg, Cornelia, Månflod, Johan, Nguyen, Han, Ackermann, Daniel, Bilz, Stefan, Burnier, Michel, Forster, Christian, Kalbermatter, Stefan, Kistler, Andreas, Pechère-Bertschi, Antoinette, Schultes, Bernd, Laimer, Markus, Rudofsky, Gottfried, Strey, Christopher, Wuerzner, Gregoire, Chiz-Tzung Chang, Hung, Cheng-Chieh, Jiang, Ju-Ying, Lee, Chien-Te, Lin, Shuei-Liong, Tarng, Der-Cherng, Tu, Shih-Te, Wu, Mai-Szu, Wu, Ming-Ju, Chuang, Lee-Ming, Deerochanawong, Chaicharn, Kitiyakara, Chagriya, Ophascharoensuk, Vuddhidej, Pongchaiyakul, Chatlert, Satirapoj, Bancha, Kosachunhanan, Natapong, Sritara, Piyamitr, Eren, Necmi, Gul, Ibrahim, Gulel, Okan, Kocyigit, Ismail, Kumbasar, Abdulbaki, Sahin, Idris, Sari, Ramazan, Sayin, Burak, Tavli, Talat, Ustundag, Sedat, Yenicerioglu, Yavuz, Badak, Ozer, Cayli, Murat, Oguz, Aytekin, Ozdogan, Oner, Sari, Ibrahim, Temizhan, Ahmet, Tigen, Mustafa, Turk, Ugur, Yilmaz, Huseyin, Yilmaz, Mehmet, Bondarets, Iryna, Botsyurko, Volodymyr, Chernikova, Viktoriia, Donets, Oleksandra, Fushtey, Ivan, Grachova, Mariia, Isayeva, Anna, Kogut, Dmytro, Komisarenko, Julia, Kravchun, Nonna, Malyar, Kateryna, Mankovsky, Borys, Martynyuk, Liliya, Maslyanko, Vitaliy, Myshanych, Halyna, Pererva, Larysa, Pertseva, Nataliia, Serhiyenko, Oleksandr, Smirnov, Ivan, Sokolova, Liubov, Stryzhak, Vasyl, Vlasenko, Maryna, Isayeva, Ganna, Larin, Oleksandr, Ahmad AbouSaleh, Barratt, Jonathan, Dang, Cuong, Kahal, Hassan, Kirk, Adam, Kilvert, Anne, Kon, Sui Phi, McCafferty, Kieran, Patel, Dipesh, Rice, Sam, Vijayaraman, Arutchelvam, Wong, Yuk-ki, Gibson, Martin, Wahba, Mona, Zaidi, Reza, Bilous, Rudy, Johnson, Andrew, Kalathil, Dhanya, Kilvert, Anne, Kyriakidou, Christina, Mathew, Amit, Mukhtar, Rasha, Munsoor, Imrozia, Poterajlo, Anton, Swift, Pauline, Idalia Acosta, Adams, Atoya, Adler, Sharon, Ajani, Dilawar, Ali, Slamat, Alicic, Radica, Al-Karadsheh, Amer, Alla, Sreedhara, Allison, D., Andrawis, Nabil, Arif, Ahmed, Awad, Ahmed, Azizad, Masoud, Bahrami, Michael, Bansal, Shweta, Barag, Steven, Barakzoy, Ahmad, Barney, Mark, Barzilay, Joshua, Bashir, Khalid, Bautista, Jose, Beddhu, Srinivasan, Belo, Diogo, Benjamin, Sabrina, Berenji, Ramin, Bhargava, Anuj, Birriel, Jose, Brietzke, Stephen, Brosius, Frank, Brusco, Osvaldo, Burgner, Anna, Busch, Robert, Canadas, Rafael, Caramori, Maria, Cardona, Jose, Case, Christopher, Cruz, Humberto, Dandillaya, Ramprasad, Dawoud, Dalia, Din, Zia, Dixon, Bradley, Doshi, Ankur, Drakakis, James, El Shahawy, Mahfouz, El-Meanawy, Ashraf, El-Shahawy, Mohammed, Evans, John, Fadda, George, Farooq, Umar, Fernando, Roland, Fink, Raymond, First, Brian, Fitz-Patrick, David, Flack, John, Fluck, Patrick, Fogelfeld, Leon, Fonseca, Vivian, Frias, Juan, Galphin, Claude, Garcia-Mayol, Luis, Goldstein, Gary, Gonzalez, Edgar, Gonzalez-Abreu, Francisco, Gore, Ashwini, Grant, David, Habwe, Violet, Hamilton, Maxine, Hammoud, Jamal, Handelsman, Stuart, Hartman, Israel, Heigerick, Glenn, Henry, Andrew, Hernandez, German, Hernandez-Cassis, Carlos, Herrera, Carlos, Hertel, Joachim, Huang, Wenyu, Iglesias, Rogelio, Iranmanesh, Ali, Jackson, Timothy, Jain, Mahendra, Jamerson, Kenneth, Johnson, Karen, Judd, Eric, Kaplan, Joshua, Kayali, Zeid, Khan, Bobby, Khan, Muhammad, Kharait, Sourabh, Kirkman, M. Sue, Kopyt, Nelson, Kotzker, Wayne, Kovesdy, Csaba, Kreit, Camil, Krishna, Arvind, Kronfli, Saeed, Lee, Keung, LeJeune, Derek, Lemus, Brenda, Leon-Forero, Carlos, Linfert, Douglas, Lora, Henry, Lurie, Alexander, Maddukuri, Geetha, Magno, Alexander, Maletz, Louis, Mandayam, Sreedhar, Markell, Mariana, Mayfield, Ronald, Mbogua, Caroline, McMullen, Dierdre, Meisner, Carl, Minton, Stephen, Mocherla, Bharat, Mohandas, Rajesh, Montero, Manuel, Moustafa, Moustafa, Nadkarni, Salil, Nakhle, Samer, Navarro, Jesus, Neyra, Nilda, Nica, Romanita, Nicol, Philip, Norwood, Paul, Numrungroad, Visal, Donovan, Richard O′, Odugbesan, A., Paoli-Bruno, Jorge, Parikh, Samir, Patel, Rakesh, Peixoto, Aldo, Pergola, Pablo, Perlman, Alan, Pettis, Karlton, Pisoni, Roberto, Ponduchi, Mirela, Posada, Jorge, Prabhakar, Sharma, Radhakrishnan, Jai, Rahman, Mahboob, Raina, Rupesh, Rastogi, Anjay, Reisin, Efrain, Rendell, Marc, Robertson, David, Rocco, Michael, Romeu, Hugo, Rosas, Sylvia, Rosenfeld, Jack, Ross, Dennis, Rothman, Jeffrey, Rudolph, Lance, Ruhullah, Yusuf, Ruoff, Gary, Ryu, Jeffrey, Sahani, Mandeep, Sam, Ramin, Samuels, Garfield, Sanchez, William, Santos, Vladimir, Satko, Scott, Saxena, Sanjeev, Scott, David, Seco, Gilberto, Seek, Melvin, Serota, Harvey, Shafi, Tariq, Shahid, Nauman, Shanik, Michael, Sharma, Santosh, Sinha, Arjun, Smelser, James, Smith, Mark, Soe, Kyaw, Solomon, Richard, Soroka, Eugene, Soufer, Joseph, Spinowitz, Bruce, Spry, Leslie, Suarez, Rosa, Subramanian, Bala, Szerlip, Harold, Tamirisa, Aparna, Thomson, Stephen, Tran, Tuan-Huy, Treger, Richard, Trullenque, Gretel, Turk, Thomas, Umpierrez, Guillermo, Urbach, Daniel, Valdes, Martin, Valika, Shujauddin, Vega, Damaris, Weissman, Peter, Whaley-Connell, Adam, Winston, Jonathan, Wise, Jonathan, Wynne, Alan, Zeig, Steven, Abdel-Rahman, Emaad, Abreu, Edel, Awad, Alaa, Bahri, Nader, Bertsch, John, Bleich, David, Bornfreund, Jonathan, Brar, Harjeet, Brian, Susan, Brinson, Cynthia, Bruschetta, Humberto, Carpio, Jose, Cohen, Steven, Cosby, John, Dhanireddy, Soni, Diaz, Jorge, Dunn, Fredrick, Eppanapally, Sabitha, Fayad, Joseph, Goel, Archana, Govindaraju, Kanakadurga, Halpern, Stephen, Jones, Audrey, Kaye, William, Knight, Herbert, Koch, Stanley, Kohli, Nandini, Lastra, Guido, Lerman, Sam, Loredo, Jorge, Lovre, Dragana, Mandviwala, Mustafa, Martin, Earl, Meyer, Jill, Murray, John, Oliver, David, Oparil, Suzanne, Penabad, Jesus, Pereira, Isabel, Popeil, Larry, Quesada, Gonzalo, Ramanathan, Kodangudi, Ramos-Gonez, Luis, Rastegar, Mandana, Rastogi, Padmashri, Rondon, Juan, Roy-Chaudhury, Prabir, Smith, David, Williamson, Don, Womack, Catherine, Yamout, Hala, Yuryev, Michael, Chu, Phuong, Van Hoang, Lam, Khanh, Tran, Phi Nga, Nguyen Thi, Son, Pham Nguyen, Tran, Lan Phuong, Le, Thuy Khuong, Nguyen, Boi Ngoc, Nguyen, Thao, Nui, Nguyen Minh, Nam, Tran Quang, and Tran, Kim Chi
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- 2023
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4. Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): A phase 3, randomized, double-blind, placebo-controlled trial
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Hites, Maya, primary, Massonnaud, Clément R., additional, Lapique, Eva Larranaga, additional, Belhadi, Drifa, additional, Jamard, Simon, additional, Goehringer, François, additional, Danion, François, additional, Reignier, Jean, additional, de Castro, Nathalie, additional, Garot, Denis, additional, Lacombe, Karine, additional, Tolsma, Violaine, additional, Faure, Emmanuel, additional, Malvy, Denis, additional, Staub, Thérèse, additional, Courjon, Johan, additional, Cazenave-Roblot, France, additional, Dyrhol Riise, Anne Ma, additional, Leturnier, Paul, additional, Martin-Blondel, Guillaume, additional, Roger, Claire, additional, Akinosoglou, Karolina, additional, Moing, Vincent Le, additional, Piroth, Lionel, additional, Sellier, Pierre, additional, Lescure, Xavier, additional, Trøseid, Marius, additional, Clevenbergh, Philippe, additional, Dalgard, Olav, additional, Gallien, Sébastien, additional, Gousseff, Marie, additional, Loubet, Paul, additional, Vardon-Bounes, Fanny, additional, Visée, Clotilde, additional, Belkhir, Leila, additional, Botelho-Nevers, Élisabeth, additional, Cabié, André, additional, Kotanidou, Anastasia, additional, Lanternier, Fanny, additional, Rouveix-Nordon, Elisabeth, additional, Silva, Susana, additional, Thiery, Guillaume, additional, Poignard, Pascal, additional, Carcelain, Guislaine, additional, Diallo, Alpha, additional, Mercier, Noémie, additional, Terzic, Vida, additional, Bouscambert-Duchamp, Maude, additional, Gaymard, Alexandre, additional, Trabaud, Mary-Anne, additional, Destras, Grégory, additional, Josset, Laurence, additional, Billard, Nicolas, additional, Han, Thi-Hong-Lien, additional, Guedj, Jérémie, additional, Couffin-Cadiergues, Sandrine, additional, Dechanet, Aline, additional, Delmas, Christelle, additional, Esperou, Hélène, additional, Fougerou-Leurent, Claire, additional, Mestre, Soizic Le, additional, Métois, Anabelle, additional, Noret, Marion, additional, Bally, Isabelle, additional, Dergan-Dylon, Sebastián, additional, Tubiana, Sarah, additional, Kalif, Ouifiya, additional, Bergaud, Nathalie, additional, Leveau, Benjamin, additional, Eustace, Joe, additional, Greil, Richard, additional, Hajdu, Edit, additional, Halanova, Monika, additional, Paiva, Jose-Artur, additional, Piekarska, Anna, additional, Rodriguez Baño, Jesus, additional, Tonby, Kristian, additional, Trojánek, Milan, additional, Tsiodras, Sotirios, additional, Unal, Serhat, additional, Burdet, Charles, additional, Costagliola, Dominique, additional, Yazdanpanah, Yazdan, additional, Peiffer-Smadja, Nathan, additional, Mentré, France, additional, and Ader, Florence, additional
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- 2024
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5. Stakeholders’ knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study
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Riordan, David O., Kinane, Mary, Walsh, Kieran A., Shiely, Frances, Eustace, Joe, and Bermingham, Margaret
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- 2020
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6. A treatment evaluator tool to monitor the real-world effectiveness of inhaled aztreonam lysine in cystic fibrosis
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Plant, Barry J, Downey, Damian G, Eustace, Joe A, Gunaratnam, Cedric, Haworth, Charles S, Jones, Andrew M, McKone, Edward F, Peckham, Daniel G, Ketchell, R. Ian, and Bilton, Diana
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- 2017
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7. Study protocol for the implementation and evaluation of the Self-harm Assessment and Management for General Hospitals programme in Ireland (SAMAGH)
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Arensman, Ella, Troya, M. Isabela, Nicholson, Sarah, Sadath, Anvar, Cully, Grace, Ramos Costa, Ana Paula, Benson, Ruth, Corcoran, Paul, Griffin, Eve, Williamson, Eileen, Eustace, Joe, Shiely, Frances, Browne, John, Rigby, Jan, Jeffers, Anne, and Cassidy, Eugene
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- 2020
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8. Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial
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European Commission, Trøseid, Marius, Arribas, José Ramón, Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Rodríguez-Baño, Jesús, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, Jose‑Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Díaz-Pollán, Beatriz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, Gastines, Lucie de, Álamo, Marta del, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., Costagliola, Dominique, EU SolidAct study group, European Commission, Trøseid, Marius, Arribas, José Ramón, Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Rodríguez-Baño, Jesús, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, Jose‑Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Díaz-Pollán, Beatriz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, Gastines, Lucie de, Álamo, Marta del, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., Costagliola, Dominique, and EU SolidAct study group
- Abstract
[Background] Baricitinib has shown efficacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifically on severe/critical COVID, including vaccinated participants., [Methods] Bari-SolidAct is a phase-3, multicentre, randomised, double-blind, placebo-controlled trial, enrolling participants from June 3, 2021 to March 7, 2022, stopped prematurely for external evidence. Patients with severe/critical COVID-19 were randomised to Baricitinib 4 mg once daily or placebo, added to standard of care. The primary endpoint was all-cause mortality within 60 days. Participants were remotely followed to day 90 for safety and patient related outcome measures., [Results] Two hundred ninety-nine patients were screened, 284 randomised, and 275 received study drug or placebo and were included in the modified intent-to-treat analyses (139 receiving baricitinib and 136 placebo). Median age was 60 (IQR 49–69) years, 77% were male and 35% had received at least one dose of SARS-CoV2 vaccine. There were 21 deaths at day 60 in each group, 15.1% in the baricitinib group and 15.4% in the placebo group (adjusted absolute difference and 95% CI − 0.1% [− 8·3 to 8·0]). In sensitivity analysis censoring observations after drug discontinuation or rescue therapy (tocilizumab/increased steroid dose), proportions of death were 5.8% versus 8.8% (− 3.2% [− 9.0 to 2.7]), respectively. There were 148 serious adverse events in 46 participants (33.1%) receiving baricitinib and 155 in 51 participants (37.5%) receiving placebo. In subgroup analyses, there was a potential interaction between vaccination status and treatment allocation on 60-day mortality. In a subsequent post hoc analysis there was a significant interaction between vaccination status and treatment allocation on the occurrence of serious adverse events, with more respiratory complications and severe infections in vaccinated participants treated with baricitinib. Vaccinated participants were on average 11 years older, with more comorbidities., [Conclusion] This clinical trial was prematurely stopped for external evidence and therefore underpowered to conclude on a potential survival benefit of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these findings warrant further investigation in other trials and real-world studies. Trial registration Bari-SolidAct is registered at NCT04891133 (registered May 18, 2021) and EUClinicalTrials.eu (2022-500385-99-00).
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- 2023
9. Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials : experience from EU‐Response and conect4children consortia
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Terzić, Vida, Levoyer, Léa, Figarella, Mélanie, Bigagli, Elisabetta, Mercier, Noémie, De Gastines, Lucie, Gibowski, Séverine, Trøseid, Marius, Demotes, Jacques, Olsen, Inge Christoffer, Hites, Maya, Ader, Florence, Lopez, José Ramón Arribas, Mentré, France, Espérou, Hélène, Costagliola, Dominique, Røttingen, John‐Arne, Poissy, Julien, Rozé, Jean‐Christophe, Warris, Adilia, O'Leary, Jackie, Fernandes, Ricardo M., Assoumou, Lambert, Hankard, Regis, Turner, Mark, Yazdanpanah, Yazdan, Diallo, Alpha, Holten, Aleksander Rygh, Barratt‐Due, Andreas, Westerheim, Elin, Colban, Martha, Tonby, Kristian, Peiffer‐Smadja, Nathan, Eustace, Joe, Keane, Ruben E., Arribàs, José R., Garcia, Irene, Mazzaferri, Fulvia, Grimaldi, David, Reuter, Jean, Staub, Therese, Berchem, Guy, Delmas, Christelle, Saillard, Juliette, Fougerou‐Leurent, Claire, Ferrane, Assia, Beniguel, Lydie, Baldé, Aliou, Belhadi, Drifa, Dechanet, Aline, Andrejak, Claire, Del Alamo, Marta, Luz, Filipa, Greil, Richard, Keuschnig, Alexandra, Hajdu, Edit, Halanova, Monika, Troníčková, Radka, Trojanek, Milan, Nerušilová, Katerina, Piekarska, Anna, Wiesner, Agnieszka, Bano, Jesus, Tsiodras, Sotirios, Ladenstein, Ruth, Vande Walle, Johan, Degraeuwe, Eva, Kvamme, Anne Mathilde H., Rajasaar, Héli, Kallio, Jaana, Papazisis, Georgios, László, Bálint, O'cleary, Jackie, Ryszard, Sot, Sousa, Catarina, Rodríguez‐Tenreiro, Carmen, Kindblom, Jenny, Ruegger, Christoph, Möller, Alexander, Hawcutt, Daniel, van der Geest, Tessa, Bruggemann, Roger, Neubert, Antje, Drouard, Anne, Dumousseaux, Marina, Moal, Anaelle, Michon, Amelie, Bouazza, Naim, Ursino, Moreno, Hervé, Magali, Boussaha, Inesse, Lozano, Helene, Gueyffier, Francois, Dilo, Ana, Negrini, Anna, Di Maggio, Lucia, Rocchi, Francesca, Polikar, Betty, Cook, Heather, EU‐Response safety group, [missing], and c4c safety group, [missing]
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Pharmacology ,paediatrics ,clinical trials ,Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11] ,drug safety ,pharmacovigilance ,public health ,Medicine and Health Sciences ,Pharmacology (medical) - Abstract
Contains fulltext : 292812.pdf (Publisher’s version ) (Open Access) Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work on PV. This initiative was put in practice by our Inserm-ANRS MIE PV department in two distinct multinational European consortia with 19 participating countries: conect4children (c4c) for paediatrics research and EU-Response for Covid-19 platform trials. The centralized PV system consists of some key procedures to harmonize the complex safety processes, creation of a local safety officer (LSO) network and centralization of all safety activities. The key procedures described the safety management plan for each trial and how tasks were shared and delegated between all stakeholders. Processing of serious adverse events (SAEs) in a unique database guaranteed the full control of the safety data and continuous evaluation of the risk-benefit ratio. The LSO network participated in efficient regulatory compliance across multiple countries. In total, there were 1312 SAEs in EU-Response and 83 SAEs in c4c in the four trials. We present here the lessons learnt from our experience in four clinical trials. We managed heterogeneous European local requirements and implemented efficient communication with all trial teams. Our approach builds capacity for PV that can be used by multiple academic sponsors.
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- 2023
10. Additional file 1 of Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial
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Trøseid, Marius, Arribas, José R., Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Baño, Jesús Rodríguez, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, José-Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Pollan, Beatriz Diaz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, de Gastines, Lucie, del Álamo, Marta, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., and Costagliola, Dominique
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Additional file 1. Online Appendix.
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- 2023
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11. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group
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Diallo, Alpha, Trøseid, Marius, Simensen, Victoria Charlotte, Boston, Anaïs, Demotes, Jacques, Olsen, Inge Christoffer, Chung, Florence, Paiva, Josél Artur, Hites, Maya, Ader, Florence, Arribas, Jose, Barratt-Due, Andreas, Melien, Øyvind, Tacconelli, Evelina, Staub, Thérèse, Greil, Richard, Tsiodras, Sotirios, Briel, Matthias, Esperou, Hélène, Mentré, France, Eustace, Joe, Saillard, Juliette, Delmas, Christelle, LeMestre, Soizic, Dumousseaux, Marina, Costagliola, Dominique, Røttingen, John-Arne, Yazdanpanah, Yazdan, Diallo, Alpha, Trøseid, Marius, Simensen, Victoria Charlotte, Boston, Anaïs, Demotes, Jacques, Olsen, Inge Christoffer, Chung, Florence, Paiva, Josél Artur, Hites, Maya, Ader, Florence, Arribas, Jose, Barratt-Due, Andreas, Melien, Øyvind, Tacconelli, Evelina, Staub, Thérèse, Greil, Richard, Tsiodras, Sotirios, Briel, Matthias, Esperou, Hélène, Mentré, France, Eustace, Joe, Saillard, Juliette, Delmas, Christelle, LeMestre, Soizic, Dumousseaux, Marina, Costagliola, Dominique, Røttingen, John-Arne, and Yazdanpanah, Yazdan
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SCOPUS: no.j, info:eu-repo/semantics/published
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- 2022
12. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results
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Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa M, Hernández García, César, Kieny, Marie-Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Abutidze, Akaki, Ader, Florence, Al-Bader, Abdullah M, Alhasawi, Almonther, Allum, Emma, Al Mawali, Adhra, Alotaibi, Athari, Alvarez-Moreno, Carlos A, Appadoo, Sheila, Arts, Derk, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bayih, Abebe Genetu, Beaumont, Helena, Bellani, Samir, Benassi, Virginia, Bhargava, Balram, Branca, Mattia, Cappel-Porter, Heike B C, Cerrato, Nery, Cheick Haidara, Fadima, Chow, Ting S, Como, Najada, Eustace, Joe, Gabunia, Tamar, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Khamis, Faryal, Kirwan, Jana, Kumar, Suresh, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María L, Miranda-Montoya, Maria C, Nel, Jeremy, Nunes, Estevao P, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi, Raza, Aun, Rees, Helen, Reges, Paula, Rogers, Chris, Salami, Kolawole, Salvadori, Marina, Sauermann, Mamatha, Sinani, Narvina, Sow, Samba, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tavares Maltez, Fernando Manuel, Teferi, Mekonnen, Tikkinen, Kari, Trelle, Sven, Tsertsvadze, Tengiz, Zaid, Hala, Rottingen, Arne, Swaminathan, Soumya, and Ryan, Michael
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BACKGROUND World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). METHODS We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. RESULTS At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. CONCLUSIONS These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).
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- 2022
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13. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group
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Diallo, Alpha Troseid, Marius Simensen, Victoria Charlotte and Boston, Anais Demotes, Jacques Olsen, Inge Christoffer and Chung, Florence Paiva, Jose Artur Hites, Maya Ader, Florence and Arribas, Jose Ramon Baratt-Due, Andreas Melien, Oyvind and Tacconelli, Evelina Staub, Therese Greil, Richard Tsiodras, Sotirios Briel, Matthias Esperou, Helene Mentre, France and Eustace, Joe Saillard, Juliette Delmas, Christelle LeMestre, Soizic Dumousseaux, Marina Costagliola, Dominique Rottingen, John-Arne Yazdanpanah, Yazdan EU-Response Investigators Grp
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- 2022
14. Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study
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Rossing, Peter, primary, Burgess, Ellen, additional, Agarwal, Rajiv, additional, Anker, Stefan D., additional, Filippatos, Gerasimos, additional, Pitt, Bertram, additional, Ruilope, Luis M., additional, Gillard, Pieter, additional, MacIsaac, Richard J., additional, Wainstein, Julio, additional, Joseph, Amer, additional, Brinker, Meike, additional, Roessig, Lothar, additional, Scott, Charlie, additional, Bakris, George L., additional, Vallejos, Augusto, additional, MacIsaac, Richard, additional, Schernthaner, Guntram, additional, Canziani, Maria Eugenia F., additional, Temelkova-Kurktschiev, Theodora, additional, Tobe, Sheldon, additional, González, Fernando, additional, Liu, Zhi-Hong, additional, Ángelo, Andrés, additional, Bonfanti, Cadena, additional, Francisco Jaramillo, Carlos, additional, Prazny, Martin, additional, Rossing, Peter, additional, Strand, Jorma, additional, Marre, Michel, additional, Schmieder, Roland, additional, Wanner, Christoph, additional, Sarafidis, Pantelis A., additional, Chan, Juliana, additional, Rosivall, László, additional, Eustace, Joseph, additional, Grossman, Ehud, additional, Yagil, Yoram, additional, Remuzzi, Giuseppe, additional, Koya, Daisuke, additional, Wada, Takashi, additional, Madero Rovalo, Magdalena, additional, Gansevoort, Ron, additional, Kooy, Adriaan, additional, Finnes, Trine, additional, De Leon, Froilan, additional, Gumprecht, Janusz, additional, Teixeira e Costa, Fernando, additional, Dreval, Alexander, additional, Vathsala, Anantharaman, additional, Amod, Aslam, additional, Gon Kim, Sin, additional, Wan Lee, Byung, additional, Pascual Santos, Julio, additional, Tengmark, Bengt-Olov, additional, Burnier, Michel, additional, Lee, Chien-Te, additional, Yamwong, Sukit, additional, Sari, Ramazan, additional, McCafferty, Kieran, additional, Mankovsky, Borys, additional, Adler, Sharon, additional, Fried, Linda, additional, Toto, Robert, additional, Williams, Mark, additional, Quang Khanh, Tran, additional, Aizenberg, Diego, additional, Bartolacci, Inés, additional, Besada, Diego, additional, Bittar, Julio, additional, Chahin, Mariano, additional, Elbert, Alicia, additional, Gelersztein, Elizabeth, additional, Liberman, Alberto, additional, Maffei, Laura, additional, Pérez Manghi, Federico, additional, Sanabria, Hugo, additional, Viñes, Gloria, additional, Wassermann, Alfredo, additional, Abhayaratna, Walter, additional, Acharya, Shamasunder, additional, Ekinci, Elif, additional, Lee, Darren, additional, Mann Mah, Peak, additional, Nelson, Craig, additional, Packham, David, additional, Pape, Alexia, additional, Roger, Simon, additional, Stephenson, Hugo, additional, Suranyi, Michael, additional, Wittert, Gary, additional, Vale, Elizabeth, additional, Clodi, Martin, additional, Ebenbichler, Christoph, additional, Fliesser-Görzer, Evelyn, additional, Hanusch, Ursula, additional, Krebs, Michael, additional, Lhotta, Karl, additional, Ludvik, Bernhard, additional, Mayer, Gert, additional, Neudorfer, Peter, additional, Paulweber, Bernhard, additional, Prager, Rudolf, additional, Preiß, Wolfgang, additional, Prischl, Friedrich, additional, Schernthaner, Gerit-Holger, additional, Sourij, Harald, additional, Wiesholzer, Martin, additional, Doubel, Peter, additional, Engelen, Wendy, additional, Hougardy, Jean-Michel, additional, Krzesinski, Jean-Marie, additional, Maes, Bart, additional, Speeckaert, Marijn, additional, Stas, Koen, additional, van Gaal, Luc, additional, Vanbelleghem, Hilde, additional, Antunes, Daniela, additional, Botelho, Roberto, additional, Brito, Claudia, additional, Canani, Luis, additional, Eugenia Canziani, Maria, additional, Cerqueira, Maria, additional, de Paula, Rogerio, additional, Eliaschewitz, Freddy, additional, Eduardo Figueiredo, Carlos, additional, Forti, Adriana, additional, Hissa, Miguel, additional, Leite Jr, Maurilo, additional, Lima, Emerson, additional, Noronha, Irene, additional, Paolino, Bruno, additional, Paschoalin, Nathalia, additional, Paschoalin, Raphael, additional, Pecoits Filho, Roberto, additional, Pereira, Marcio, additional, Portes, Evandro, additional, Precoma, Dalton, additional, Rea, Rosangela, additional, Riella, Miguel, additional, Eduardo Salles, Joao, additional, Vasconcellos, Eduardo, additional, Vencio, Sergio, additional, Apostolova, Emiliya, additional, Boshnyashka, Radostina, additional, Farah, Ghassan, additional, Georgiev, Dimitar, additional, Gushterova, Valentina, additional, Klyuchkova, Neli, additional, Lucheva, Mariya, additional, Manova, Petya, additional, Minkova, Dotska, additional, Nonchev, Boyan, additional, Pichmanova, Mariyana, additional, Prakova, Zhulieta, additional, Rangelov, Rangel, additional, Rashkov, Rosen, additional, Stanchev, Pavel, additional, Stoyanovska-Elencheva, Bilyana, additional, Tagarev, Zhivko, additional, Temelkova-Kurktschieva, Theodora, additional, Vasileva, Svetla, additional, Yoncheva-Mihaylova, Mariana, additional, Barre, Paul, additional, Carlson, Brian, additional, Conway, James, additional, Cournoyer, Serge, additional, Dumas, Richard, additional, Fikry, Sameh, additional, Goluch, Richard, additional, Hamet, Pavel, additional, Hart, Randolph, additional, Henein, Sam, additional, Liutkus, Joanne, additional, Madore, Francois, additional, Martinho, Valdemar, additional, Mazza, Giuseppe, additional, McFarlane, Philip, additional, O'Keefe, Dennis, additional, Peterson, Sean, additional, Schwartz, Daniel, additional, Shu, Daniel, additional, Steele, Andrew, additional, Tellier, Guy, additional, Tennankore, Karthik, additional, Tsoukas, George, additional, Tytus, Richard, additional, Vitou, Louise, additional, Walsh, Michael, additional, Weisnagel, Stanley, additional, Wilderman, Igor, additional, Yale, Jean-Francois, additional, Cobos, Jorge, additional, Godoy, Juan, additional, Lobos, Sergio, additional, Carlos Palma, Juan, additional, Carlos Prieto, Juan, additional, Reyes, Eliana, additional, Romero, Carmen, additional, Saavedra, Victor, additional, Vega, Mario, additional, Bu, Ruifang, additional, Cai, Hanqing, additional, Chen, Nan, additional, Chen, Qinkai, additional, Chen, Dejun, additional, Cheng, Jinluo, additional, Dong, Youping, additional, Dong, Junwu, additional, Guan, Tianjun, additional, Hao, Chuanming, additional, Huang, Wen, additional, Jiang, Fangfang, additional, Lei, Minxiang, additional, Li, Ling, additional, Li, Zhonghe, additional, Li, Xuemei, additional, Li, Jingmei, additional, Li, Yan, additional, Liang, Xinling, additional, Liang, Bo, additional, Liu, Fang, additional, Liu, Yinghong, additional, Liu, Yuantao, additional, Liu, Zhihong, additional, Long, Gang, additional, Lu, Guoyuan, additional, Lu, Weiping, additional, Lu, Yibing, additional, Luo, Ping, additional, Ma, Jianhua, additional, Mo, Zhaohui, additional, Niu, Jianying, additional, Peng, Ai, additional, Shen, Jiansong, additional, Shen, Feixia, additional, Shi, Bingyin, additional, Su, Qing, additional, Sun, Zhuxing, additional, Tang, Shuifu, additional, Tong, Nanwei, additional, Wang, Hao, additional, Wang, Xinjun, additional, Wang, Lihua, additional, Wang, Guixia, additional, Wang, Jianqin, additional, Wang, Yangang, additional, Wang, Li, additional, Wei, Jiali, additional, Wu, Tianfeng, additional, Wu, Chaoqing, additional, Xing, Changying, additional, Xiong, Fei, additional, Xu, Xudong, additional, Xu, Ning, additional, Yan, Tiekun, additional, Yang, Jinkui, additional, Yin, Aiping, additional, Zeng, Longyi, additional, Zhang, Hao, additional, Zhang, Yanlin, additional, Zhang, Ying, additional, Zhao, Wenjing, additional, Zhao, Zhiquan, additional, Zheng, Hongguang, additional, Zhong, Ling, additional, Zhu, Dalong, additional, Zhuang, Yongze, additional, Arango, Clara, additional, Barrera, Sandra, additional, Beltrán López, Nelly, additional, Benitez, Diego, additional, Blanco, Guillermo, additional, Cadena, Andrés, additional, Coronel, Julian, additional, Cure, Carlos, additional, Durán, Carlos, additional, González, Alexander, additional, Guzmán, Gustavo, additional, Hernández, Eric, additional, Ibarra, Jaime, additional, Jaramillo, Carlos, additional, Jaramillo, Nicolás, additional, Kattah, William, additional, Molina, Dora, additional, Sánchez, Gregorio, additional, Terront, Mónica, additional, Trujillo, Freddy, additional, Urina, Miguel, additional, Vargas, Ruben, additional, Villegas, Iván, additional, Yupanqui, Hernán, additional, Alferi, Dino, additional, Brada, Michal, additional, Brezina, Jiri, additional, Bucek, Petr, additional, Edelsberger, Tomas, additional, Gulakova, Drahomira, additional, Hasalova Zapletalova, Jitka, additional, Hola, Olga, additional, Hornova, Lucie, additional, Houdova, Jana, additional, Hrmova, Helena, additional, Karasek, David, additional, Kopecka, Sarka, additional, Kovar, Richard, additional, Krcova, Eva, additional, Kuchar, Jiri, additional, Kutejova, Vlasta, additional, Lubanda, Hana, additional, Matyasek, Ivo, additional, Mokrejsova, Magdalena, additional, Okenka, Libor, additional, Pumprla, Jiri, additional, Tomanek, Pavel, additional, Bech, Jesper, additional, Faber, Jens, additional, Gislason, Gunnar, additional, Hangaard, Jørgen, additional, Jaroslaw Pacyk, Grzegorz, additional, Juhl, Claus, additional, Krarup, Thure, additional, Lindhardt, Morten, additional, Madsbad, Sten, additional, Nielsen, Joan, additional, Pedersen-Bjergaard, Ulrik, additional, Poulsen, Per, additional, Rasmussen, Ole, additional, Schousboe, Karoline, additional, Honkasalo, Mikko, additional, Humaloja, Kari, additional, Kananen, Kristiina, additional, Kantola, Ilkka, additional, Koistinen, Arvo, additional, Korsoff, Pirkko, additional, Lahtela, Jorma, additional, Nieminen, Sakari, additional, Nieminen, Tuomo, additional, Sadeharju, Karita, additional, Sulosaari, Sakari, additional, Cariou, Bertrand, additional, Chantrel, François, additional, Clavel, Sylvaine, additional, Combe, Christian, additional, Fauvel, Jean-Pierre, additional, Gallouj, Karim, additional, Gouet, Didier, additional, Guerci, Bruno, additional, Guerrot, Dominique, additional, Hourmant, Maryvonne, additional, Klein, Alexandre, additional, Mariat, Christophe, additional, Mesbah, Rafik, additional, Le Meur, Yannick, additional, Monier, Arnaud, additional, Moranne, Olivier, additional, Serusclat, Pierre, additional, Vendrely, Benoit, additional, Verges, Bruno, additional, Zaoui, Philippe, additional, Axthelm, Christoph, additional, Bergmann, Andreas, additional, Birkenfeld, Andreas L., additional, Braun, Hermann, additional, Busch, Klaus, additional, Contzen, Christel, additional, Degenhardt, Stefan, additional, Derwahl, Karl, additional, Giebel, Thomas, additional, Hagenow, Andreas, additional, Haller, Hermann, additional, Hasslacher, Christoph, additional, Horacek, Thomas, additional, Jungmair, Wolfgang, additional, Kloos, Christof, additional, Koch, Thorsten, additional, Krüger, Thilo, additional, Mühlfeld, Anja, additional, Müller, Joachim, additional, Pfützner, Andreas, additional, Pistrosch, Frank, additional, Rose, Ludger, additional, Rump, Lars, additional, Schettler, Volker, additional, Schiefke, Ingolf, additional, Schlichthaar, Heike, additional, Schröppel, Bernd, additional, Schürholz, Thomas, additional, Sigal, Helena, additional, Stemler, Lutz, additional, Strack, Georg, additional, Täschner, Heidrun, additional, Toursarkissian, Nicole, additional, Tschöpe, Diethelm, additional, Ulmer, Achim, additional, van der Giet, Markus, additional, Winkelmann, Bernhard R., additional, Boletis, Ioannis, additional, Hatziagelaki, Erifili, additional, Ioannidis, Ioannis, additional, Kounadi, Theodora, additional, Makriniotou, Ioanna, additional, Papadopoulou, Dorothea, additional, Papagianni, Aikaterini, additional, Passadakis, Ploumis, additional, Stefanidis, Ioannis, additional, Pang Ip, Tai, additional, Lee, Paul, additional, Yan Andrea Luk, On, additional, Wang, Angela, additional, Yeung, Vincent, additional, Bajcsi, Dora, additional, Danos, Peter, additional, Harcsa, Eleonora, additional, Kazup, Szilvia, additional, Keltai, Katalin, additional, Kirschner, Robert, additional, Kiss, Julianna, additional, Kovacs, Laszlo, additional, Lamboy, Beata, additional, Literati-Nagy, Botond, additional, Mileder, Margit, additional, Nagy, Laszlo, additional, Noori, Ebrahim, additional, Nyirati, Gabor, additional, Petro, Gizella, additional, Schneider, Karoly, additional, Szocs, Albert, additional, Vasas, Szilard, additional, Wudi, Krisztina, additional, Zilahi, Zsolt, additional, Zsom, Marianna, additional, Eustace, Joe, additional, Holian, John, additional, Reddan, Donal, additional, O'Meara, Yvonne, additional, Abramof Ness, Rosane, additional, Adawi, Faiad, additional, Armaly, Zaher, additional, Atar, Shaul, additional, Ben Chetrit, Sydney, additional, Berar Yanay, Noa, additional, Chernin, Gil, additional, Darawsha, Mahmud, additional, Efrati, Shai, additional, Elias, Mazen, additional, Farber, Evgeny, additional, Glandt, Mariela, additional, Halabi, Majdi, additional, Khazim, Khaled, additional, Liberty, Idit, additional, Mosenzon, Ofri, additional, Nimer, Assy, additional, Schwartz, Doron, additional, Zukermann, Robert, additional, Ilieva Parvanova, Aneliya, additional, Avogaro, Angelo, additional, Giorgio Battaglia, Giovanni, additional, Tiziano Bevilacqua, Maurizio, additional, Bonora, Enzo, additional, Antonio Bossi, Carlo, additional, Calabrò, Paolo, additional, Luigi Cavalot, Franco, additional, Cimino, Roberto, additional, Gennaro Cozzolino, Mario, additional, David, Salvatore, additional, Emdin, Michele, additional, Fiaccadori, Enrico, additional, Fiorina, Paolo, additional, Bruno Giorda, Carlo, additional, Cristina Gregorini, Maria, additional, La Manna, Gaetano, additional, Carlo Maggi, Davide, additional, Manti, Roberta, additional, Meregalli, Giancarla, additional, Pani, Antonello, additional, Perico, Norberto, additional, Piatti, PierMarco, additional, Pisani, Antonio, additional, Ettore Pontiroli, Antonio, additional, Ponzani, Paola, additional, Santorelli, Gennaro, additional, Santoro, Domenico, additional, Scanziani, Renzo, additional, Teatini, Ugo, additional, Tonolo, Giancarlo, additional, Trevisan, Roberto, additional, Maria Veronelli, Anna, additional, Luciano Viviani, Giorgio, additional, Araki, Hideo, additional, Ebisui, Osamu, additional, Fujita, Naruhiro, additional, Furuya, Ryuichi, additional, Hamamoto, Yoshiyuki, additional, Hatazaki, Masahiro, additional, Hayashi, Terumasa, additional, Higashi, Takayuki, additional, Hirohata, Yoshihide, additional, Horinouchi, Shuji, additional, Inagaki, Masayuki, additional, Ishii, Masao, additional, Ishiko, Tamayo, additional, Jinnouchi, Hideaki, additional, Kanai, Hidetoshi, additional, Kanda, Daisuke, additional, Kanehara, Hideo, additional, Kashima, Masayuki, additional, Kato, Kiyoe, additional, Katsuki, Takeshi, additional, Kawamitsu, Katsunori, additional, Kawasaki, Satsuki, additional, Kikuchi, Fumi, additional, Kikuchi, Hidetoshi, additional, Kobayashi, Kunihisa, additional, Koide, Junko, additional, Kubota, Miyuki, additional, Kusano, Yoshiro, additional, Maeda, Hajime, additional, Matsubayashi, Sunao, additional, Matsumoto, Kazunari, additional, Matsuo, Yasuto, additional, Matsuoka, Naoki, additional, Miyaoka, Hiroaki, additional, Murao, Satoshi, additional, Nakayama, Mikihiro, additional, Nakazawa, Jun, additional, Nomiyama, Takashi, additional, Noritake, Masayuki, additional, Ogiwara, Takayuki, additional, Ohashi, Hiroshi, additional, Okamoto, Hideki, additional, Osonoi, Takeshi, additional, Sasaki, Nobuhiro, additional, Sekigami, Taiji, additional, Shibasaki, Taro, additional, Shibata, Hirotaka, additional, Shinoda, Junji, additional, Sobajima, Hiroshi, additional, Sugitatsu, Kazuya, additional, Sugiura, Toshiyuki, additional, Sugiyama, Toru, additional, Suzuki, Daisuke, additional, Suzuki, Hiroyuki, additional, Suzuki, Masaaki, additional, Takeda, Asami, additional, Tanaka, Asami, additional, Tanaka, Seiichi, additional, Tsunematsu, Izumi, additional, Ujihara, Makoto, additional, Yamada, Daishiro, additional, Yamada, Masayo, additional, Yamagata, Kazuo, additional, Yamakawa, Ken, additional, Yamakawa, Fumiko, additional, Yamasaki, Yoshimitsu, additional, Yambe, Yuko, additional, Yanagida, Taihei, additional, Yanai, Hidekatsu, additional, Yasuda, Tetsuyuki, additional, Kriauciuniene, Dovile, additional, Lasiene, Jurate, additional, Navickas, Antanas, additional, Radzeviciene, Lina, additional, Urbanaviciene, Egle, additional, Urbonas, Gediminas, additional, Velaviciene, Audrone, additional, Abd Ghani, Rohana, additional, Azizah Aziz, Nor, additional, Yuan Lee, Li, additional, Loong Loh, Chek, additional, Mohd Ali, Norhaliza, additional, Mohd Noor, Nurain, additional, Nur Fatnoon, Nik, additional, Ahmad, Nik, additional, Ratnasingam, Jeyakantha, additional, Hasnul Halimi Bin, Wan, additional, Hasan, Wan, additional, Mohd Izani, Wan, additional, Mohamed, Wan, additional, Avila Pardo, Sandro, additional, Bastidas Adrian, Miriam, additional, Chew Wong, Alfredo, additional, Escobedo de la Peña, Jorge, additional, Fanghänel Salmón, Guillermo, additional, González Gálvez, Guillermo, additional, Gutiérrez Ochoa, Ramiro, additional, Irizar Santana, Saúl, additional, Méndez Machado, Gustavo, additional, Nevarez Ruiz, Luis, additional, Ramos Ibarra, Denisse, additional, Ramos López, Gabriel, additional, Sauque Reyna, Leobardo, additional, Solache Ortiz, Gustavo, additional, Valdez Ortiz, Rafael, additional, Villagordoa Mesa, Juan, additional, Bakker, R.C., additional, Barendregt, J.N.M., additional, Boonstra, A.H., additional, Bos, Willem, additional, Brouwer, C.B., additional, van Buren, M., additional, Krekels, Marielle, additional, van Leendert, Ruud J.M., additional, Lieverse, Louis A.G., additional, Luik, P.T., additional, Lars Penne, E., additional, Smak Gregoor, Peter, additional, Vogt, Liffert, additional, Baker, John, additional, Crawford, Veronica, additional, Cutfield, Rick, additional, Dunn, Peter, additional, Krebs, Jeremy, additional, Nirmalaraj, Kingsley, additional, Scott, Russell, additional, Smuts, Nine, additional, Eriksen, Erik, additional, Høivik, Hans, additional, Karlsson, Thomas, additional, Scott Munk, Peter, additional, Radtke, Maria, additional, Risberg, Knut, additional, Rocke, Jan, additional, Solnør, Leidulv, additional, Stenehjem, Aud-Eldrid, additional, Tafjord, Anne-Beathe, additional, Pamugas, Glenda, additional, Panelo, Araceli, additional, Perez, Ronald, additional, Tanque, Maribel, additional, Tirador, Louie, additional, Villa, Michael, additional, Butrymowicz, Patrycja, additional, Ciechanowski, Kazimierz, additional, Cieslik, Grazyna, additional, Franek, Edward, additional, Hoffmann, Michal, additional, Krzykowska, Jolanta, additional, Kurnatowska, Ilona, additional, Landa, Katarzyna, additional, Madrzejewski, Adam, additional, Madziarska, Katarzyna, additional, Mazur, Stanislaw, additional, Napora, Piotr, additional, Nowicki, Michal, additional, Ocicka-Kozakiewicz, Anna, additional, Rewerska, Barbara, additional, Rusicka, Teresa, additional, Ruxer, Jan, additional, Skokowska, Ewa, additional, Stankiewicz, Andrzej, additional, Stompor, Tomasz, additional, Tiuryn-Petrulewicz, Agnieszka, additional, Wasilewska, Katarzyna, additional, Wierusz-Wysocka, Bogna, additional, Wnetrzak-Michalska, Renata, additional, Almeida, Edgar, additional, Ballesteros, Rosa, additional, Barreto, Carlos, additional, Beirao, Idalina, additional, Birne, Rita, additional, Esteves, Cesar, additional, Guia, Jose, additional, Heitor, Susana, additional, Marques, Olinda, additional, Melo, Pedro, additional, Nolasco, Fernando, additional, Pereira, Amalia, additional, Roque, Cristina, additional, Rosario, Francisco, additional, Silva, Gil, additional, Silva, Ana, additional, Vila Lobos, Ana, additional, Cortes-Maisonet, Gregorio, additional, Roman-Miranda, Amaury, additional, Albota, Adrian, additional, Bala, Cornelia, additional, Barbonta, Hortensia, additional, Caceaune, Elena, additional, Catrinoui, Doina, additional, Constantin, Ciprian, additional, Dumitrescu, Adriana, additional, Mindrescu, Nicoleta, additional, Mistode, Cristina, additional, Negrisanu, Gabriela, additional, Onaca, Adriana, additional, Paveliu, Silvia, additional, Pintilei, Ella, additional, Pop, Lavinia, additional, Popa, Amorin, additional, Popescu, Alexandrina, additional, Radulian, Gabriela, additional, Szilagyi, Iosif, additional, Turcu, Liana, additional, Vacaru, Georgeta, additional, Vlad, Adrian, additional, Antsiferov, Mikhail, additional, Arkhipov, Mikhail, additional, Babkin, Andrey, additional, Barbarash, Olga, additional, Baranov, Vitaliy, additional, Chernyavskaya, Elena, additional, Demko, Arkadiy, additional, Edin, Anton, additional, Ermakova, Polina, additional, Fadeev, Valentin, additional, Galyavich, Albert, additional, Gaysina, Leyla, additional, Gordeev, Ivan, additional, Ipatko, Irina, additional, Kalashnikova, Marina, additional, Khalimov, Yuriy, additional, Klimontov, Vadim, additional, Kobalava, Zhanna, additional, Kosmacheva, Elena, additional, Koziolova, Natalya, additional, Kvitkova Sergey Levashov, Lyudmila, additional, Libis, Roman, additional, Marasaev, Vyacheslav, additional, Malykh, Natalia, additional, Martynenko, Vladimir, additional, Malyutina, Sofya, additional, Merai, Imad, additional, Mkrtumyan, Ashot, additional, Nechaeva, Galina, additional, Petunina, Nina, additional, Palyutin, Shamil, additional, Pimenov, Leonid, additional, Rechkova, Elena, additional, Rodionova, Tatyana, additional, Rymar, Oksana, additional, Sardinov, Ruslan, additional, Semenova, Olga, additional, Sherenkov, Alexander, additional, Solovev, Oleg, additional, Smolyarchuk, Elena, additional, Strongin, Leonid, additional, Ukhanova, Olga, additional, Verlan, Nadezhda, additional, Vorokhobina, Natalya, additional, Yakhontov, Davyd, additional, Yakushin, Sergey, additional, Zakharova, Elena, additional, Zalevskaya, Alsu, additional, Zanozina, Olga, additional, Zhdanova, Elena, additional, Zhukova, Larisa, additional, Zykova, Tatyana, additional, Fang Sum, Chee, additional, Muhummad Suhail, Sufi, additional, San Tan, Ru, additional, Wong, Edmund, additional, Babikova, Jana, additional, Buganova, Ingrid, additional, Dzupina, Andrej, additional, Ochodnicka, Zuzana, additional, Sosovec, Dalibor, additional, Spodniakova, Denisa, additional, Ahmed, Fayzal, additional, Bhana, Sindeep, additional, Distiller, Larry, additional, Jansen van Rensburg, Dirkie, additional, Joshi, Mukesh, additional, Joshi, Shaifali, additional, Lakha, Deepak, additional, Mitha, Essack, additional, Podgorski, Gracjan, additional, Ranjith, Naresh, additional, Rayner, Brian, additional, Rheeder, Paul, additional, Sarvan, Mohamed, additional, Seeber, Mary, additional, Siebert, Heidi, additional, Tayob, Mohammed, additional, Trokis, Julien, additional, Urbach, Dorothea, additional, van Zyl, Louis, additional, Choi, Bum-Soon, additional, Gi Choi, Moon, additional, Chung, ChoonHee, additional, Hwang, YouCheol, additional, Kim, ChongHwa, additional, Kim, InJoo, additional, Kim, JaeHyeon, additional, Kim, SinGon, additional, Kim, SungGyun, additional, Hee Kim, Tae, additional, Lee, WooJe, additional, Lee, ByungWan, additional, Wook Lee, Kang, additional, Oh, Kook-Hwan, additional, Eun Oh, Ji, additional, Kyu Oh, Yun, additional, Oh, Dong-Jin, additional, Park, Junbeom, additional, Joon Shin, Seok, additional, Sung, Su-Ah, additional, Myung Yu, Jae, additional, Agraz, Irene, additional, Javier Ampudia, Francisco, additional, Bouarich, Hanane, additional, Calero, Francesca, additional, Castro, Cristina, additional, Cigarrán Guldris, Secundino, additional, Cruzado Garrit, Josep, additional, de Álvaro, Fernando, additional, Galcerán, Josep, additional, González Albarrán, Olga, additional, Hernández Jaras, Julio, additional, Ibernón, Meritxell, additional, Martínez Deben, Francisco, additional, Dolores Martínez Esteban, Ma, additional, María Pascual Izuel, José, additional, Martins, Judith, additional, Mediavilla, Juan, additional, Michán, Alfredo, additional, Poch, Esteban, additional, Polaina Rusillo, Manuel, additional, Sánchez Juan, Carlos, additional, Santamaría Olmo, Rafael, additional, Julián, José, additional, de la Morena, Segura, additional, Soto, Alfonso, additional, Troya, Maribel, additional, Bruchfeld, Annette, additional, Curiac, Dan, additional, Eliasson, Ken, additional, Frank, Malin, additional, Guron, Gregor, additional, Hellberg, Olof, additional, Hellgren, Margareta, additional, Larnefeldt, Hans, additional, Lindholm, Carl-Johan, additional, Löndahl, Magnus, additional, Rein-Hedin, Erik, additional, Soveri, Inga, additional, Spaak, Jonas, additional, Ackermann, Daniel, additional, Bilz, Stefan, additional, Forster, Christian, additional, Kalbermatter, Stefan, additional, Kistler, Andreas, additional, Pechére-Bertschi, Antoinette, additional, Schultes, Bernd, additional, Chang, Chiz-Tzung, additional, Hung, Cheng-Chieh, additional, Jiang, Ju-Ying, additional, Lin, Shuei-Liong, additional, Tarng, Der-Cherng, additional, Tu, Shih-Te, additional, Wu, Mai-Szu, additional, Wu, Ming-Ju, additional, Deerochanawong, Chaicharn, additional, Kitiyakara, Chagriya, additional, Ophascharoensuk, Vuddhidej, additional, Pongchaiyakul, Chatlert, additional, Satirapoj, Bancha, additional, Eren, Necmi, additional, Gul, Ibrahim, additional, Gulel, Okan, additional, Kocyigit, Ismail, additional, Kumbasar, Abdulbaki, additional, Sahin, Idris, additional, Sayin, Burak, additional, Tavli, Talat, additional, Ustundag, Sedat, additional, Yenicerioglu, Yavuz, additional, Bondarets, Iryna, additional, Botsyurko, Volodymyr, additional, Chernikova, Viktoriia, additional, Donets, Oleksandra, additional, Fushtey, Ivan, additional, Grachova, Mariia, additional, Isayeva, Anna, additional, Kogut, Dmytro, additional, Komisarenko, Julia, additional, Kravchun, Nonna, additional, Malyar, Kateryna, additional, Martynyuk, Liliya, additional, Maslyanko, Vitaliy, additional, Myshanych, Halyna, additional, Pererva, Larysa, additional, Pertseva, Nataliia, additional, Serhiyenko, Oleksandr, additional, Smirnov, Ivan, additional, Sokolova, Liubov, additional, Stryzhak, Vasyl, additional, Vlasenko, Maryna, additional, AbouSaleh, Ahmad, additional, Barratt, Jonathan, additional, Dang, Cuong, additional, Kahal, Hassan, additional, Kirk, Adam, additional, Kilvert, Anne, additional, Phi Kon, Sui, additional, Patel, Dipesh, additional, Rice, Sam, additional, Vijayaraman, Arutchelvam, additional, Wong, Yuk-ki, additional, Gibson, Martin, additional, Wahba, Mona, additional, Zaidi, Reza, additional, Acosta, Idalia, additional, Adams, Atoya, additional, Ajani, Dilawar, additional, Ali, Slamat, additional, Alicic, Radica, additional, Al-Karadsheh, Amer, additional, Alla, Sreedhara, additional, Allison, D., additional, Andrawis, Nabil, additional, Arif, Ahmed, additional, Awad, Ahmed, additional, Azizad, Masoud, additional, Bahrami, Michael, additional, Bansal, Shweta, additional, Barag, Steven, additional, Barakzoy, Ahmad, additional, Barney, Mark, additional, Barzilay, Joshua, additional, Bashir, Khalid, additional, Bautista, Jose, additional, Beddhu, Srinivasan, additional, Belo, Diogo, additional, Benjamin, Sabrina, additional, Berenji, Ramin, additional, Bhargava, Anuj, additional, Birriel, Jose, additional, Brietzke, Stephen, additional, Brosius, Frank, additional, Brusco, Osvaldo, additional, Burgner, Anna, additional, Busch, Robert, additional, Canadas, Rafael, additional, Caramori, Maria, additional, Cardona, Jose, additional, Case, Christopher, additional, Cruz, Humberto, additional, Dandillaya, Ramprasad, additional, Dawoud, Dalia, additional, Din, Zia, additional, Dixon, Bradley, additional, Doshi, Ankur, additional, Drakakis, James, additional, El Shahawy, Mahfouz, additional, El-Meanawy, Ashraf, additional, El-Shahawy, Mohammed, additional, Evans, John, additional, Fadda, George, additional, Farooq, Umar, additional, Fernando, Roland, additional, Fink, Raymond, additional, First, Brian, additional, Fitz-Patrick, David, additional, Flack, John, additional, Fluck, Patrick, additional, Fogelfeld, Leon, additional, Fonseca, Vivian, additional, Frias, Juan, additional, Galphin, Claude, additional, Garcia-Mayol, Luis, additional, Goldstein, Gary, additional, Gonzalez, Edgar, additional, Gonzalez-Abreu, Francisco, additional, Gore, Ashwini, additional, Grant, David, additional, Habwe, Violet, additional, Hamilton, Maxine, additional, Hammoud, Jamal, additional, Handelsman, Stuart, additional, Hartman, Israel, additional, Heigerick, Glenn, additional, Henry, Andrew, additional, Hernandez, German, additional, Hernandez-Cassis, Carlos, additional, Herrera, Carlos, additional, Hertel, Joachim, additional, Huang, Wenyu, additional, Iglesias, Rogelio, additional, Iranmanesh, Ali, additional, Jackson, Timothy, additional, Jain, Mahendra, additional, Jamerson, Kenneth, additional, Johnson, Karen, additional, Judd, Eric, additional, Kaplan, Joshua, additional, Kayali, Zeid, additional, Khan, Bobby, additional, Khan, Muhammad, additional, Kharait, Sourabh, additional, Sue Kirkman, M., additional, Kopyt, Nelson, additional, Kotzker, Wayne, additional, Kovesdy, Csaba, additional, Kreit, Camil, additional, Krishna, Arvind, additional, Kronfli, Saeed, additional, Lee, Keung, additional, LeJeune, Derek, additional, Lemus, Brenda, additional, Leon-Forero, Carlos, additional, Linfert, Douglas, additional, Lora, Henry, additional, Lurie, Alexander, additional, Maddukuri, Geetha, additional, Magno, Alexander, additional, Maletz, Louis, additional, Mandayam, Sreedhar, additional, Markell, Mariana, additional, Mayfield, Ronald, additional, Mbogua, Caroline, additional, McMullen, Dierdre, additional, Meisner, Carl, additional, Minton, Stephen, additional, Mocherla, Bharat, additional, Mohandas, Rajesh, additional, Montero, Manuel, additional, Moustafa, Moustafa, additional, Nadkarni, Salil, additional, Nakhle, Samer, additional, Navarro, Jesus, additional, Neyra, Nilda, additional, Nica, Romanita, additional, Nicol, Philip, additional, Norwood, Paul, additional, Numrungroad, Visal, additional, O'Donovan, Richard, additional, Odugbesan, A., additional, Paoli-Bruno, Jorge, additional, Parikh, Samir, additional, Patel, Rakesh, additional, Peixoto, Aldo, additional, Pergola, Pablo, additional, Perlman, Alan, additional, Pettis, Karlton, additional, Pisoni, Roberto, additional, Ponduchi, Mirela, additional, Posada, Jorge, additional, Prabhakar, Sharma, additional, Radhakrishnan, Jai, additional, Rahman, Mahboob, additional, Raina, Rupesh, additional, Rastogi, Anjay, additional, Reisin, Efrain, additional, Rendell, Marc, additional, Robertson, David, additional, Rocco, Michael, additional, Romeu, Hugo, additional, Rosas, Sylvia, additional, Rosenfeld, Jack, additional, Ross, Dennis, additional, Rothman, Jeffrey, additional, Rudolph, Lance, additional, Ruhullah, Yusuf, additional, Ruoff, Gary, additional, Ryu, Jeffrey, additional, Sahani, Mandeep, additional, Sam, Ramin, additional, Samuels, Garfield, additional, Sanchez, William, additional, Santos, Vladimir, additional, Satko, Scott, additional, Saxena, Sanjeev, additional, Scott, David, additional, Seco, Gilberto, additional, Seek, Melvin, additional, Serota, Harvey, additional, Shafi, Tariq, additional, Shahid, Nauman, additional, Shanik, Michael, additional, Sharma, Santosh, additional, Sinha, Arjun, additional, Smelser, James, additional, Smith, Mark, additional, Soe, Kyaw, additional, Solomon, Richard, additional, Soroka, Eugene, additional, Soufer, Joseph, additional, Spinowitz, Bruce, additional, Spry, Leslie, additional, Suarez, Rosa, additional, Subramanian, Bala, additional, Szerlip, Harold, additional, Tamirisa, Aparna, additional, Thomson, Stephen, additional, Tran, Tuan-Huy, additional, Treger, Richard, additional, Trullenque, Gretel, additional, Turk, Thomas, additional, Umpierrez, Guillermo, additional, Urbach, Daniel, additional, Valdes, Martin, additional, Valika, Shujauddin, additional, Vega, Damaris, additional, Weissman, Peter, additional, Whaley-Connell, Adam, additional, Winston, Jonathan, additional, Wise, Jonathan, additional, Wynne, Alan, additional, Zeig, Steven, additional, Chu, Phuong, additional, Van Hoang, Lam, additional, Khanh, Tran, additional, Thi Phi Nga, Nguyen, additional, Nguyen Son, Pham, additional, and Phuong Tran, Lan, additional
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- 2022
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15. Efficacy and Safety of Baricitinib for the Treatment of Hospitalized Adults with Severe or Critical COVID-19 (Bari-SolidAct): A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Trial
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Trøseid, Marius, primary, Arribas, JR, additional, Assoumou, Lambert, additional, Holten, Aleksander Rygh, additional, Poissy, Julien, additional, Terzić, Vida, additional, Mazzaferri, Fulvia, additional, Rodríguez-Baño, Jesús , additional, Eustace, Joe, additional, Hites, Maya, additional, Joannidis, Michael, additional, Paiva, Jose-Artur, additional, Reuter, Jean, additional, Püntmann, Isabel, additional, Patrick-Brown, Thale, additional, Westerheim, Elin, additional, Nezvalova-Henriksen, Katerina, additional, Beniguel, Lydie, additional, Dahl, Tuva Børresdatter, additional, Bouscambert-Duchamp, Maude, additional, Halanova, Monika, additional, Peterfi, Zoltan, additional, Tsiodras, Sotirios, additional, Rezek, Michael, additional, Briel, Matthias, additional, Unal, Serhat, additional, Schlegel, Martin, additional, Ader, Florence, additional, Lacombe, Karine, additional, Amdal, Cecilie Delphin, additional, Serge Rodrigues, Serge Rodrigues, additional, Tonby, Kristian, additional, Gaudet, Alexandre, additional, Heggelund, Lars, additional, Mootien, Joy, additional, Johannessen, Asgeir, additional, Møller, Jannicke Horjen, additional, Diaz Pollan, Beatriz, additional, Tveita, Anders, additional, Kildal, Anders Benjamin, additional, Richard, Jean-Christophe, additional, Dalgard, Olav, additional, Simensen, Victoria Charlotte, additional, Baldé, Aliou, additional, de Gastines, Lucie, additional, del Álamo, Marta, additional, Aydin, Burç, additional, Lund-Johansen, Fridtjof, additional, Trabaud, Mary-Anne, additional, Diallo, Alpha, additional, Halvorsen, Bente, additional, Røttingen, John-Arne, additional, Tacconelli, Evelina, additional, Yadanapanah, Yazdan, additional, Olsen, Inge Christoffer, additional, and Costagliola, Dominique, additional
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- 2022
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16. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group
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Diallo, Alpha, primary, Trøseid, Marius, additional, Simensen, Victoria Charlotte, additional, Boston, Anaïs, additional, Demotes, Jacques, additional, Olsen, Inge Christoffer, additional, Chung, Florence, additional, Paiva, José Artur, additional, Hites, Maya, additional, Ader, Florence, additional, Arribas, Jose Ramon, additional, Baratt-Due, Andreas, additional, Melien, Øyvind, additional, Tacconelli, Evelina, additional, Staub, Thèrèse, additional, Greil, Richard, additional, Tsiodras, Sotirios, additional, Briel, Matthias, additional, Esperou, Hélène, additional, Mentré, France, additional, Eustace, Joe, additional, Saillard, Juliette, additional, Delmas, Christelle, additional, LeMestre, Soizic, additional, Dumousseaux, Marina, additional, Costagliola, Dominique, additional, Røttingen, John-Arne, additional, and Yazdanpanah, Yazdan, additional
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- 2022
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17. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.
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UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, UCL - (SLuc) Service de médecine interne générale, WHO Solidarity Trial Consortium, Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa M, Hernández García, César, Kieny, Marie-Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Ader, Florence, Al-Bader, Abdullah M, Alhasawi, Almonther, Allum, Emma, Alotaibi, Athari, Alvarez-Moreno, Carlos A, Appadoo, Sheila, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bellani, Samir, Branca, Mattia, Cappel-Porter, Heike B C, Cerrato, Nery, Chow, Ting S, Como, Najada, Eustace, Joe, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Kirwan, Jana, Kumar, Suresh, Lennon, Peter, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Maguire, Teresa, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María L, Miranda-Montoya, Maria C, Nel, Jeremy, Nunes, Estevao P, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi R, Raza, Aun, Rees, Helen, Reges, Paula P S, Rogers, Chris A, Salami, Kolawole, Salvadori, Marina I, Sinani, Narvina, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tikkinen, Kari A O, Trelle, Sven, Zaid, Hala, Røttingen, John-Arne, Swaminathan, Soumya, Belkhir, Leïla, UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, UCL - (SLuc) Service de médecine interne générale, WHO Solidarity Trial Consortium, Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa M, Hernández García, César, Kieny, Marie-Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Ader, Florence, Al-Bader, Abdullah M, Alhasawi, Almonther, Allum, Emma, Alotaibi, Athari, Alvarez-Moreno, Carlos A, Appadoo, Sheila, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bellani, Samir, Branca, Mattia, Cappel-Porter, Heike B C, Cerrato, Nery, Chow, Ting S, Como, Najada, Eustace, Joe, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Kirwan, Jana, Kumar, Suresh, Lennon, Peter, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Maguire, Teresa, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María L, Miranda-Montoya, Maria C, Nel, Jeremy, Nunes, Estevao P, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi R, Raza, Aun, Rees, Helen, Reges, Paula P S, Rogers, Chris A, Salami, Kolawole, Salvadori, Marina I, Sinani, Narvina, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tikkinen, Kari A O, Trelle, Sven, Zaid, Hala, Røttingen, John-Arne, Swaminathan, Soumya, and Belkhir, Leïla
- Abstract
BACKGROUND: World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). METHODS: We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. RESULTS: At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11).
- Published
- 2021
18. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.
- Author
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WHO Solidarity Trial Consortium, Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa MM, Hernández García, César, Kieny, Marie Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Ader, Florence, Al-Bader, Abdullah AM, Alhasawi, Almonther, Allum, Emma, Alotaibi, Athari, Alvarez-Moreno, Carlos CA, Appadoo, Sheila, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bellani, Samir, Branca, Mattia, Cappel-Porter, Heike HBC, Cerrato, Nery, Chow, Ting TS, Como, Najada, Eustace, Joe, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Tahiri Joutei Hassani, Mehdi, Hassany, Mohamed, Hites, Maya, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Kirwan, Jana, Kumar, Princy Suresh, Lennon, Peter, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Maguire, Teresa, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María ML, Miranda-Montoya, Maria MC, Nel, Jeremy, Nunes, Estevao EP, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi MR, Raza, Aun, Rees, Helen, Reges, Paula PPS, Rogers, Chris A, Salami, Kolawole, Salvadori, Marina I, Sinani, Narvina, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tikkinen, Kari KAO, Trelle, Sven, Zaid, Hala, Røttingen, John-Arne, Swaminathan, Soumya, WHO Solidarity Trial Consortium, Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa MM, Hernández García, César, Kieny, Marie Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Ader, Florence, Al-Bader, Abdullah AM, Alhasawi, Almonther, Allum, Emma, Alotaibi, Athari, Alvarez-Moreno, Carlos CA, Appadoo, Sheila, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bellani, Samir, Branca, Mattia, Cappel-Porter, Heike HBC, Cerrato, Nery, Chow, Ting TS, Como, Najada, Eustace, Joe, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Tahiri Joutei Hassani, Mehdi, Hassany, Mohamed, Hites, Maya, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Kirwan, Jana, Kumar, Princy Suresh, Lennon, Peter, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Maguire, Teresa, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María ML, Miranda-Montoya, Maria MC, Nel, Jeremy, Nunes, Estevao EP, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi MR, Raza, Aun, Rees, Helen, Reges, Paula PPS, Rogers, Chris A, Salami, Kolawole, Salvadori, Marina I, Sinani, Narvina, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tikkinen, Kari KAO, Trelle, Sven, Zaid, Hala, Røttingen, John-Arne, and Swaminathan, Soumya
- Abstract
World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19)., info:eu-repo/semantics/published
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- 2021
19. Additional file 2 of Study protocol for the implementation and evaluation of the Self-harm Assessment and Management for General Hospitals programme in Ireland (SAMAGH)
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Arensman, Ella, M. Isabela Troya, Nicholson, Sarah, Sadath, Anvar, Cully, Grace, Costa, Ana Paula Ramos, Benson, Ruth, Corcoran, Paul, Griffin, Eve, Williamson, Eileen, Eustace, Joe, Shiely, Frances, Browne, John, Rigby, Jan, Jeffers, Anne, and Cassidy, Eugene
- Subjects
TheoryofComputation_LOGICSANDMEANINGSOFPROGRAMS ,ComputingMilieux_MISCELLANEOUS - Abstract
Additional file 2. Facilities of the ASSERT centre. Photographs of simulation labs used in the training at the ASSERT centre.
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- 2020
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20. Additional file 3 of Study protocol for the implementation and evaluation of the Self-harm Assessment and Management for General Hospitals programme in Ireland (SAMAGH)
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Arensman, Ella, M. Isabela Troya, Nicholson, Sarah, Sadath, Anvar, Cully, Grace, Costa, Ana Paula Ramos, Benson, Ruth, Corcoran, Paul, Griffin, Eve, Williamson, Eileen, Eustace, Joe, Shiely, Frances, Browne, John, Rigby, Jan, Jeffers, Anne, and Cassidy, Eugene
- Abstract
Additional file 3. Baseline Questionnaire SAMAGH. Baseline Questionnaire used as part of process evaluation.
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- 2020
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21. Additional file 1 of Study protocol for the implementation and evaluation of the Self-harm Assessment and Management for General Hospitals programme in Ireland (SAMAGH)
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Arensman, Ella, M. Isabela Troya, Nicholson, Sarah, Sadath, Anvar, Cully, Grace, Costa, Ana Paula Ramos, Benson, Ruth, Corcoran, Paul, Griffin, Eve, Williamson, Eileen, Eustace, Joe, Shiely, Frances, Browne, John, Rigby, Jan, Jeffers, Anne, and Cassidy, Eugene
- Abstract
Additional file 1. Identification of highly lethal self-harm. Table summarising identification of highly lethal self-harm.
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- 2020
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22. A study to define the microbiome of the asthmatic airway
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Hunt, Eoin, primary, Ward, Chris, additional, Lapthorne, Susan, additional, Eustace, Joe, additional, O'Byrne, Paul, additional, Plant, Barry, additional, MacSharry, John, additional, Murphy, Desmond, additional, and Sullivan, Ashley, additional
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- 2017
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23. A study to assess airway remodelling and the utility of low dose CT scoring to evaluate the asthmatic airway
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Hunt, Eoin, primary, James, Karl, additional, Ward, Chris, additional, Power, Stephen, additional, Sullivan, Ashley, additional, Eustace, Joe, additional, O'Byrne, Paul, additional, Plant, Barry, additional, Maher, Michael, additional, MacSharry, John, additional, and Murphy, Desmond, additional
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- 2017
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24. A REVIEW OF EDUCATIONAL INTERVENTIONS FOR ADULTS WITH CYSTIC FIBROSIS
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Vagg, Tamara, primary, Plant, Barry, additional, Eustace, Joe, additional, and Tabirca, Sabin, additional
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- 2017
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25. A WEB-BASED 3D LUNG ANATOMY LEARNING ENVIRONMENT USING GAMIFICATION
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Vagg, Tamara, primary, Plant, Barry, additional, Ronan, Nicola, additional, Tabirca, Sabin, additional, and Eustace, Joe, additional
- Published
- 2016
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26. INTERACTIVE VISUALISER WITH AUDIO FOR CYSTIC FIBROSIS EDUCATION.
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Vagg, Tamara, primary, Plant, Barry, additional, Tabirca, Sabin, additional, and Eustace, Joe, additional
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- 2015
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27. A WEB-BASED 3D LUNG ANATOMY LEARNING ENVIRONMENT USING GAMIFICATION.
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VAGG, Tamara, TABIRCA, Sabin, RONAN, Nicola, PLANT, Barry J., and EUSTACE, Joe
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VISUAL learning ,GAMIFICATION ,LUNGS ,ANATOMY education in universities & colleges ,BRONCHOSCOPY ,MEDICAL students - Abstract
The bronchial tree structure is a complex form within the human lung. It consists of many intertwining pipes which decrease in size and increase in number as you travel deeper into the structure. To amplify the difficulty this poses, visual learning aids accessible to students both in a lab environment and self-learning environment are generally two dimensional. Gamification techniques for education and eLearning have been proven beneficial in advancing many area of medical pedagogy. This paper presents a system intended to disseminate lung anatomy knowledge to medical students, as well as novice bronchoscopists. To achieve this, a 3D bronchial structure was modelled to match that of schematic drawings provided to medical students. This model was then imported into a 3D learning system that had been created using a game engine and designed for deployment on a web-based platform. This framework provides a learning environment in which the user can navigate through the bronchial pipes and interact with interest points to learn about the anatomical structure. The framework also includes a quiz environment, adapting the interest points as quiz questions. The quiz includes dynamically generated feedback, providing a means of self-assessment for the user. This environment also incorporates game metaphors such as points of interest, levels, objectives, and a heads up display (HUD). Similarly, the environment uses player pawn flying navigation with keyboard and mouse input, reflecting the navigation found in many first-person games. Future developments for this system involve the inclusion of pathologies to compliment anatomical knowledge. It is also anticipated that the system will be further extended to include other pedagogical content regarding the thoracic cavity. [ABSTRACT FROM AUTHOR]
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- 2016
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28. Development and Progress of Ireland's Biobank Network: Ethical, Legal, and Social Implications (ELSI), Standardized Documentation, Sample and Data Release, and International Perspective
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Mee, Blanaid, primary, Gaffney, Eoin, additional, Glynn, Sharon A., additional, Donatello, Simona, additional, Carroll, Paul, additional, Connolly, Elizabeth, additional, Garrigle, Sarah Mc, additional, Boyle, Terry, additional, Flannery, Delia, additional, Sullivan, Francis J., additional, McCormick, Paul, additional, Griffin, Mairead, additional, Muldoon, Cian, additional, Fay, Joanna, additional, O'Grady, Tony, additional, Kay, Elaine, additional, Eustace, Joe, additional, Burke, Louise, additional, Sheikh, Asim A., additional, Finn, Stephen, additional, Flavin, Richard, additional, and Giles, Francis J., additional
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- 2013
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29. Can a biobank network and supporting infrastructure enhance Ireland's ability to attract pharmaceutical research and development and clinical trial opportunities? A pilot survey.
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Mee, Blanaid, Gaffney, Eoin, McGarrigle, Sarah, Glynn, Sharon A., Connolly, Elisabeth M., McCormick, Paul H., Flannery, Delia, O'Connor, Katrina, Lawson, Margaret, Ryan, Lisa, Nugent, Timothy, Ward, Ronan, Sullivan, Francis J., Fay, Joanna, O'Grady, Tony, Kay, Elaine, Eustace, Joe, Burke, Louise, Finn, Stephen, and Flavin, Richard
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- 2016
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30. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results
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Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa M, Hernández García, César, Kieny, Marie-Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Ader, Florence, Al-Bader, Abdullah M, Alhasawi, Almonther, Allum, Emma, Alotaibi, Athari, Alvarez-Moreno, Carlos A, Appadoo, Sheila, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bellani, Samir, Branca, Mattia, Cappel-Porter, Heike B C, Cerrato, Nery, Chow, Ting S, Como, Najada, Eustace, Joe, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Kirwan, Jana, Kumar, Suresh, Lennon, Peter, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Maguire, Teresa, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María L, Miranda-Montoya, Maria C, Nel, Jeremy, Nunes, Estevao P, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi R, Raza, Aun, Rees, Helen, Reges, Paula P S, Rogers, Chris A, Salami, Kolawole, Salvadori, Marina I, Sinani, Narvina, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tikkinen, Kari A O, Trelle, Sven, Zaid, Hala, Røttingen, John-Arne, and Swaminathan, Soumya
- Subjects
3. Good health - Abstract
BACKGROUND World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). METHODS We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. RESULTS At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. CONCLUSIONS These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).
31. Supporting employees with mental illness and reducing mental illness-related stigma in the workplace: an expert survey
- Author
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Hogg, Bridget, Moreno-Alcázar, Ana, Tóth, Mónika Ditta, Serbanescu, Ilinca, Aust, Birgit, Leduc, Caleb, Paterson, Charlotte, Tsantilla, Fotini, Abdulla, Kahar, Cerga-Pashoja, Arlinda, Cresswell-Smith, Johanna, Fanaj, Naim, Meksi, Andia, Ni Dhalaigh, Doireann, Reich, Hanna, Ross, Victoria, Sanches, Sarita, Thomson, Katherine, Van Audenhove, Chantal, Pérez, Victor, Arensman, Ella, Purebl, Gyorgy, Amann, Benedikt L., O’Connor, Ainslie, Szekely, Andras, LaMontagne, Anthony, Como, Ariel, Dushaj, Arilda, Doukani, Asmae, Justicia, Azucena, Greiner, Birgit A., Lockwood, Chris, O’Connor, Cliodhna, McDaid, David, Kim, Dooyoung, Williamson, Eileen, Griffin, Eve, Coppens, Evelien, Burazeri, Genc, Qirjako, Gentiana, Davey, Grace, van Weeghel, Jaap, Eustace, Joe, Kilroy, Joseph, Hug, Juliane, Kolves, Kairi, Mulcahy, Karen, Michell, Karen, Wahlbeck, Kristian, de Winter, Lars, Cox, Laura, D’Alessandro, Luigia, Maxwell, Margaret, Reavley, Nicola, Trembeczky, Peter, Corcoran, Paul, Rugulies, Reiner, Benson, Ruth, Rapeli, Saara, Ihinonvien, Sarah, Mustafa, Sevim, Mathieu, Sharna, Hackel, Stefan, King, Tanya, Hegerl, Ulrich, Scott, Vanda, and Orchard, Wendy
- Subjects
DISORDERS ,Clinical Neurology ,Anxiety ,Expert survey ,HEALTH-RELATED STIGMA ,H Social Sciences ,RA0421 Public health. Hygiene. Preventive Medicine ,Pharmacology (medical) ,Workplace ,COGNITIVE-BEHAVIORAL THERAPY ,Biological Psychiatry ,Psychiatry ,WORK ,Science & Technology ,Depression ,SME ,General Medicine ,CARE ,Stigma ,Psychiatry and Mental health ,PROMOTION ,Mental illness ,PREVENTION INTERVENTIONS ,Neurosciences & Neurology ,CONSENSUS ,Life Sciences & Biomedicine - Abstract
An expert survey was designed to support the development of a workplace-based multi-country intervention tackling depression, anxiety, and mental illness-related stigma in small- and medium-sized enterprises (SMEs). Academic experts and representatives of SME organisations, specific sector organisations, labour or advocacy groups, and occupational health organisations, were contacted across eight European countries and Australia. The survey comprised closed and open text questions to assess expert opinion about interventions for employees with mental health difficulties, interventions supporting their managers, and anti-stigma interventions. The survey was available in six languages. The online platform Qualtrics was used for data collection. Quantitative data was analysed through descriptive statistics and qualitative data was analysed through thematic analysis. Sixty-five of 146 experts responded, representing a 42% response rate. Results showed only 26.2% of experts agreed that employees could speak openly about mental health issues, and 81.5% of experts indicated a large or medium unmet need for support for employees with mental health issues. Psychoeducational materials, face-to-face workshops and interventions based on cognitive behavioural therapy were ranked most likely to be taken up by employees. Experts rated as most useful for managers' guidelines on how to act if an employee has mental health issues (67.7%). The greatest number of experts indicated workshops of people with lived experience of mental illness (80.0%) and awareness campaigns (78.5%) were most required to tackle stigma. Responses were consistent between experts from different countries and areas of expertise. Experts in this multinational survey assessed that interventions supporting mental health in the workplace and tackling stigma are greatly needed. A multicomponent intervention with a wide range of materials and tools is supported. ispartof: EUROPEAN ARCHIVES OF PSYCHIATRY AND CLINICAL NEUROSCIENCE vol:273 issue:3 ispartof: location:Germany status: Published online
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32. Repurposed Antiviral Drugs for Covid-19 : Interim WHO Solidarity Trial Results
- Author
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WHO Solidarity Trial Consortium, Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Karim, Quarraisha Abdool, Alejandria, Marissa M., Hernández García, César, Kieny, Marie-Paul, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K. Srinath, Periago, Mirta Roses, Hanna, Pierre Abi, Ader, Florence, Al-Bader, Abdullah M., Alhasawi, Almonther, Allum, Emma, Alotaibi, Athari, Alvarez-Moreno, Carlos A., Appadoo, Sheila, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bellani, Samir, Branca, Mattia, Cappel-Porter, Heike B. C., Cerrato, Nery, Chow, Ting S., Como, Najada, Eustace, Joe, García, Patricia J., Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Kirwan, Jana, Kumar, Suresh, Lennon, Peter, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Maguire, Teresa, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T., Mesa Rubio, María L., Miranda-Montoya, Maria C., Nel, Jeremy, Nunes, Estevao P., Perola, Markus, Portolés, Antonio, Rasmin, Menaldi R., Raza, Aun, Rees, Helen, Reges, Paula P. S., Rogers, Chris A., Salami, Kolawole, Salvadori, Marina I., Sinani, Narvina, Sterne, Jonathan A. C., Stevanovikj, Milena, Tacconelli, Evelina, Tikkinen, Kari A. O., Trelle, Sven, Zaid, Hala, Røttingen, John-Arne, and Swaminathan, Soumya
- Subjects
3. Good health - Abstract
BACKGROUND World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19). METHODS We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. RESULTS At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. CONCLUSIONS These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.)
33. Studying glomerular disease epidemiology: tackling challenges and paving a path forward
- Author
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O'Shaughnessy, Michelle Marie, Eustace, Joe, and Shiely, Frances
- Subjects
Glomerular disease ,Glomerulonephritis ,urogenital system ,Epidemiology - Abstract
Background: Glomerular diseases are a group of rare immune-mediated kidney diseases that affect the glomeruli, or filtering units, of the kidney. Major knowledge gaps remain in our understanding of glomerular disease epidemiology. Efforts to describe glomerular disease distributions based on geographic, demographic, and temporal factors (descriptive epidemiology) are limited by the absence of population-level disease registries in most jurisdictions. The extent to which glomerular disease subtype independently associates with clinical outcomes (analytic epidemiology), especially once kidney disease has progressed to end-stage kidney failure, remains largely unknown. Further, much of what is known regarding glomerular disease epidemiology is derived from the experiences of highly-selected patient populations enrolled in clinical trials or attending academic medical centres. Larger-scale, population-level, studies of glomerular disease epidemiology would help to close knowledge gaps regarding the distribution and determinants of glomerular disease and, in doing so, would inform clinical care, public health policy, and clinical trial design. Hypotheses: Two major hypotheses are explored in this thesis: 1. Significant geographic and temporal variation in glomerular disease frequencies exist, that are not solely explained by racial-ethnic variation, thus supporting a role for socioeconomic and environmental factors in the development of clinically manifest glomerular disease; 2. Glomerular disease subtype independently associates with clinical outcomes even after glomerular disease has advanced to end-stage kidney failure, challenging the prevailing paradigm to group all glomerular disease subtypes together in research and public health reporting of clinical outcomes in patients with end-stage kidney failure. Aims: The overall aim of this research was to close knowledge gaps in glomerular disease epidemiology by identifying geographic and temporal variation in glomerular disease frequency distributions and by determining associations between glomerular disease subtype and clinical outcomes (mortality, cardiovascular events) in patients with end-stage kidney failure. Methods: For the first two manuscripts (Chapters 3 and 4), I analysed two large-scale pathology datasets created by my collaborator, Dr. Charles Jeannette: a) the International Kidney Biopsy Survey (IKBS) that includes kidney biopsy diagnoses and associated patient demographics from 29 international kidney pathology laboratories, which I used to study geographic variation in glomerular disease frequencies within and across racial-ethnic groups; b) the Glomerular Disease Collaborative Network (GDCN), a registry of all kidney biopsies referred to the University of North Carolina since 1986, which I used to study temporal trends in glomerular disease frequencies within and across demographic groups over the last three decades. For the next two manuscripts (Chapters 5 and 6), I analysed data – including physician-reported cause of kidney failure – from virtually all U.S. patients with treated end-stage kidney failure who are enrolled, by federal mandate, in the United States Renal Data System (USRDS). In the first of these two manuscripts, I determined associations between glomerular disease subtype and mortality; in the second, I determined associations between glomerular disease subtype and cardiovascular events. Advanced statistical methods included multivariable regression to handle confounding, proportional sub-distribution hazard models to handle competing events, and multiple imputation to handle missing data. Results: Major findings from these manuscripts include: a) significant differences in glomerular disease frequencies across continents, even among patients with similar racial-ethnic backgrounds; b) significant temporal trends in the relative frequencies of many biopsy-proven glomerular diseases, including stabilization in the 21st century of the rapid increase in focal segmental glomerulosclerosis observed at the end of the 20th century, and a dramatic increase in diabetic glomerulosclerosis over time, to become the second most frequent biopsy-proven glomerular disease diagnosis in the modern era; c) significant differences in the hazards of mortality and cardiovascular events across glomerular disease subtypes, even after accounting for between-group differences in case-mix. Conclusions: In addition to answering specific research questions regarding glomerular disease epidemiology, this research exemplifies the strengths and feasibility of population-level, internationally collaborative, approaches to studying glomerular diseases. Findings from these studies can shape public health policy (e.g. promotion of healthy lifestyle approaches to curb the high frequency of diabetic glomerulosclerosis in contemporary U.S. populations), future research design (e.g. recognising the importance of glomerular disease subtype as a prognostic indicator in studies involving patients with end-stage kidney failure), and clinical care (e.g. formulating differential diagnoses based on patient demographics, or counselling U.S. patients regarding their absolute and relative risks of mortality and cardiovascular events following dialysis initiation).
- Published
- 2020
34. Clinical outcomes of real-world Kalydeco (ivacaftor); Cork study - understanding the implications of CFTR modulation
- Author
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Ronan, Nicola J., Plant, Barry, and Eustace, Joe
- Subjects
congenital, hereditary, and neonatal diseases and abnormalities ,CFTR modulation ,respiratory system ,Cystic fibrosis ,respiratory tract diseases ,Ivacaftor - Abstract
CF represents one of the success stories of modern medicine with sustained incremental increases in survival from one of childhood death to one of adulthood survival. Traditionally the management of CF has focused on treating the consequences of CFTR dysfunction. The advent of ivacaftor offers the opportunity to evaluate the effect of restoration of CFTR function on CF lung disease and extrapulmonary manifestations. Global prevalence of the G551D mutation is 4%. Prevalance at Cork CF centre is 23%. Thus this work evaluates the effect of CFTR modulation on clinical parameters, Chest CT, lung microbiota, gut microbiota, gut inflammation, pancreatic function and benefit to the individual patient.
- Published
- 2020
35. Dietary phosphorus in chronic kidney disease
- Author
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Byrne, Fiona Nora, Eustace, Joe, Kiely, Mairead, Shiely, Frances, and Kearney, Patricia M.
- Subjects
Hyperphosphataemia ,Potassium ,Phosphorus ,Phytate ,Diet - Abstract
Hyperphosphataemia is common in the later stages of chronic kidney disease and is a universal problem in end stage kidney disease, where it is associated with increased morbidity and mortality. Treatment includes a low phosphorus diet, that imposes numerous dietary restrictions, lacks a robust evidence base and in current practice fails to distinguish between phytate and non phytate bound phosphorus. The overall aim of this PhD was to provide the evidence basis for a revised low phosphorus diet, and to assess its effectiveness, safety and tolerability. Specific aims were 1) to define revised dietary recommendations for phosphorus in chronic kidney disease and to translate these recommendations into food based advice, 2) to conduct a proof of concept acute feeding study in prevalent haemodialysis patients using the modified diet and 3) to investigate the effectiveness of the modified diet in a multicentre randomised controlled trial in prevalent haemodialysis patients. To update the traditional low phosphorus diet, as chair of a national working group of Irish renal dietitians, I undertook a narrative review of the available renal nutrition literature. We combined the evidence with clinical experience and expertise to update the traditional low phosphorus diet. The modified diet, agreed by consensus, relaxed the restrictions of phytate bound phosphorus, and introduced previously disallowed foods such as pulses, peas, nuts and more whole grains. To ensure adequate but not excessive protein intake, we introduced guidance on bread and cereal intakes and included some advice based on phosphorus to protein ratios. Finally we increased the focus on avoiding phosphate additives. These changes were incorporated into a modified renal diet. The modified diet was initially evaluated against the standard low phosphorus diet in an in-centre, directly observed, one day, cross-over feeding study in order to examine the immediate postprandial effects of the modified diet. We demonstrated that the modified diet blunted post-prandial hyperphosphataemia, was not associated with increased hyperkalaemia and was well tolerated. Given the results of the acute feeding study, we conducted a national multicentre randomised controlled trial, comparing the modified low phosphorus diet with the standard low phosphorus diet in 74 prevalent patients treated with maintenance haemodialysis. The modified renal diet, with its broader food choice, achieved a significantly higher fibre intake, was well tolerated and provided comparable serum phosphate and potassium control as the standard renal diet. Based on the evidence from this project, a decision was taken by the Irish Renal Interest Group of the Irish and Dietetic Institute in January 2019, to endorse the modified low phosphorus diet and to implement it nationally.
- Published
- 2020
36. Implementation of risk based monitoring into academic led clinical trials in Ireland
- Author
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Hurley, Caroline, Eustace, Joe, Kearney, Patricia M., Shiely, Frances, Clark, Mike, and Flanagan, Evelyn
- Subjects
Clinical trial ,Risk based monitoring - Abstract
Introduction: In November 2016, the International Conference on Harmonsation (ICH) published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This process is more commonly known as Risk Based Monitoring (RBM). However, evidence suggested that a gold standard validated approach to RBM did not exist and it was unclear how sponsors would introduce RBM into their clinical trials units (CTUs). In 2014, Ireland, unlike countries such as Switzerland and the UK, did not have a national strategy to support the introduction of RBM into its publicly funded, academic-led CTUs. The absence of a national strategy and gold standard RBM approach meant it was not clear how RBM would be implemented in CTUs. Therefore, the overarching aim of this thesis was to develop, implement and evaluate a quality improvement intervention to support the introduction of RBM into academic-led clinical trials in Ireland. Methods: This thesis employed a multi-method research strategy directed by the Knowledge to Action (KTA) framework over four years from October 2014 to October 2018. The KTA framework is a conceptual framework to assist the translation of knowledge into sustainable, evidence-based interventions. This thesis used a range of research methods, implemented in four separate sequential phases, to address different components of the KTA framework which primarily involve knowledge creation and knowledge translations. The four phases first involved systematically reviewing the existing evidence of RBM methods. Then, in a mixed method study, I explored the attitudes, and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. Next, I did a document analysis study to examine the experience of monitoring in a clinical trial. Finally, I developed the quality improvement study by combining the results of the three earlier phases to identify the most appropriate quality improvement intervention to support RBM use in academic led clinical trials in Ireland. Results: The systematic review showed several tools exist to support the implementation of RBM. The mixed methods study showed a need for training and regulatory endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The document analysis showed that on-site and centralised monitoring can be used simultaneously to fulfil ICH GCP’s seventeen monitoring requirements. The findings of these three studies were combined and a brief, face-to-face, interactive education workshop was identified as an effective way to encourage RBM tool usage among clinical researchers working in academic-led clinical trials in Ireland. Conclusion: Applying the KTA framework to empirical data has led to an intervention that is implementable in clinical practice and has the potential to positively change monitoring practices of clinical researchers. This thesis provides critical evidence on the complexities associated with implementing RBM in academic-led clinical trials. It provides practical recommendations to guide clinical researchers who wish to perform RBM.
- Published
- 2018
37. Economic evaluations of clinical pharmacy services in Ireland, 2007-2015
- Author
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Gallagher, James, Byrne, Stephen, Mccarthy, Suzanne, Woods, Noel, and Eustace, Joe
- Subjects
Clinical pharmacy ,Pharmacy ,Health economics ,health care economics and organizations ,Economic evaluation - Abstract
Introduction The concept of this thesis was driven by stagnation within the Irish healthcare system. Multiple reports from pharmacy organisations had outlined possible future directions for the profession but progress was minimal, especially in comparison with other countries. The author’s directive was to evaluate the economic impact of a series of clinical pharmacy services (CPS) in hospital and community settings. Methods A systematic review of economic evaluations of clinical pharmacy services in hospital patients was undertaken to gain insight into recent research in the field. Eligible studies were evaluated using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), to establish the quality, consistency and transparency of relevant research. A retrospective analysis of an internal hospital pharmacy interventions database was conducted. A method first described by Nesbit et al. was implemented to estimate the level of cost avoidance achieved. A cost-effectiveness analysis based on data from a randomised controlled trial of a pharmacist-supervised patient self-testing (PST) of warfarin therapy is presented. Outcome measure was the incremental cost associated with six months of intervention management. A similar cost-effectiveness analysis based on previously published RCT data was used to evaluate a novel structured pharmacist review of medication in older hospitalised patients. Cost-effectiveness analysis was presented in the form of an incremental cost-effectiveness ratio (ICER). An ICER is an additional cost per unit effect, in the case of this study, the cost of preventing an additional non-trivial ADR in hospital. A method described by Preaud et al. was adapted to estimate the clinical and economic benefit gained from vaccination of patients by a community pharmacist in Ireland in 2013/14. Sample demographic data was obtained from a national chain of community pharmacies and applied to overall national vaccination data. Results Systematic review identified twenty studies which were eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15%) were deemed to be “good-quality” studies. No ‘novel’ clinical pharmacist intervention was identified during the course of this review. Analysis of internal hospital database identified 4,257 interventions documented on 2,147 individual patients over a 12 month period. Substantial cost avoidance of €710,000 was generated over a 1 year period from the perspective of the health care provider. Mean cost avoidance of €166 per intervention was generated. The cost of providing these interventions was €82,000. Substantial net cost-benefits of €626,279 and a cost-benefit ratio of 8.64 : 1 were generated based on this evaluation of pharmacist interventions. Results from an evaluation of a novel pharmacist-led form of warfarin management indicated indicated that on a per patient basis, PST was slightly more expensive than established anticoagulant management. On a per patient basis over a six month period, PST resulted in an incremental cost of €59.08 in comparison with routine care. Overall cost of managing a patient through pharmacist-supervised PST for a six month period is €226.45. However, for this increase in cost a clinically significant improvement in care was provided. Patients achieved a significantly higher time in therapeutic range during the PST arm in comparison with routine care, (72 ± 19.7% vs 59 ± 13.5%). Difference in overall cost was minimal and PST was the dominant strategy in some scenarios examined during sensitivity analysis. Structured pharmacist review of medication was determined to be dominant in comparison to usual pharmaceutical care. Even if the healthcare payer was unwilling to pay any money for the prevention of an ADR, the intervention strategy is still likely to be cost-effective (probability of being determined cost-effective = 0.707). Implementation of pharmacist-led influenza vaccination has resulted in substantial clinical and economic benefits to the healthcare system. The majority of patients (64.9%) who availed of this service had identifiable influenza-related risk factors. Of patients with influenza-related risk factors, age ≥65 year was the most commonly cited risk factor. Pharmacist vaccination services averted a total of 848 influenza cases across all age groups during the 2013/2014 influenza season. Due to receipt of vaccination in a pharmacy setting, 444 influenza-related GP visits were prevented. In terms of more serious influenza-associated events, 11 hospitalisations and five influenza-related deaths were averted. Costs averted were approximately €305,000. These were principally wider societal-related costs associated with lost productivity. Conclusion Overall, clinical pharmacy services are adding value to the Irish healthcare system in both hospital and community settings, but provision of additional funding for new services would enable them to offer a great deal more.
- Published
- 2016
38. Vascular calcification and mineral bone disorder in chronic kidney disease
- Author
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Kinsella, Sinéad and Eustace, Joe
- Subjects
Kidneys--Diseases ,Mineral bone disorder ,Chronic kidney disease ,Hyperparathyroidism ,Renal transplantation ,Kidneys--Transplantation ,Vascular calcification - Abstract
Chronic Kidney Disease (CKD), osteoporosis and mild hyponatremia are all prevalent chronic conditions that may coexist and are often under-recognized. Mineral-Bone Disorder begins early in the natural history of CKD and results in complex abnormalities of bone which ultimately confers a well-established increased risk of fragility fractures in End Stage Kidney Disease. Hyponatremia is a novel, usually renal mediated metabolic perturbation, that most commonly occurs independently of the stage of renal dysfunction but which may also predispose to increased fracture risk. The extent -if any- to which either early stages of renal dysfunction or the presence of hyponatremia contribute to fracture occurrence in the general population, independently of osteoporosis, is unclear. Renal transplantation is the treatment of choice for ESKD and although it restores endogenous renal function it typically fails to normalize either the long term cardiovascular or fracture risk. One potential mechanism contributing to these elevated long-term risks and to diminished Health Related Quality of Life is persistent, post-transplant hyperparathyroidism. In this study we retrospectively examine the association of renal function and serum sodium with Bone Mineral Density and fracture occurrence in a retrospective cohort of 1930 female members of the general population who underwent routine DXA scan. We then prospectively recruited a cohort of 90 renal transplant recipients in order to examine the association of post transplant parathyroid hormone (PTH) level with measures of CKD Mineral Bone Disorder, including, DXA Bone Mineral Density, Vascular Calcification (assessed using both abdominal radiography and CT techniques, as well as indirectly by carotid-femoral Pulse Wave Velocity) and Quality of Life (using the Short Form-12 and a PTH specific symptom score). In the retrospective DXA cohort, moderate CKD (eGFR 30-59ml/min/1.73m2) and hyponatremia (
- Published
- 2013
39. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.
- Author
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Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, Alejandria MM, Hernández García C, Kieny MP, Malekzadeh R, Murthy S, Reddy KS, Roses Periago M, Abi Hanna P, Ader F, Al-Bader AM, Alhasawi A, Allum E, Alotaibi A, Alvarez-Moreno CA, Appadoo S, Asiri A, Aukrust P, Barratt-Due A, Bellani S, Branca M, Cappel-Porter HBC, Cerrato N, Chow TS, Como N, Eustace J, García PJ, Godbole S, Gotuzzo E, Griskevicius L, Hamra R, Hassan M, Hassany M, Hutton D, Irmansyah I, Jancoriene L, Kirwan J, Kumar S, Lennon P, Lopardo G, Lydon P, Magrini N, Maguire T, Manevska S, Manuel O, McGinty S, Medina MT, Mesa Rubio ML, Miranda-Montoya MC, Nel J, Nunes EP, Perola M, Portolés A, Rasmin MR, Raza A, Rees H, Reges PPS, Rogers CA, Salami K, Salvadori MI, Sinani N, Sterne JAC, Stevanovikj M, Tacconelli E, Tikkinen KAO, Trelle S, Zaid H, Røttingen JA, and Swaminathan S
- Subjects
- Adenosine Monophosphate therapeutic use, Aged, Alanine therapeutic use, Antiviral Agents administration & dosage, Antiviral Agents adverse effects, COVID-19 mortality, Drug Therapy, Combination, Female, Hospital Mortality, Hospitalization, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Length of Stay, Male, Middle Aged, Respiration, Artificial, Treatment Failure, Adenosine Monophosphate analogs & derivatives, Alanine analogs & derivatives, Antiviral Agents therapeutic use, Hydroxychloroquine therapeutic use, Interferon beta-1a therapeutic use, Lopinavir therapeutic use, COVID-19 Drug Treatment
- Abstract
Background: World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19)., Methods: We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry., Results: At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration., Conclusions: These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.)., (Copyright © 2020 Massachusetts Medical Society.)
- Published
- 2021
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