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1. Blood culture-free ultra-rapid antimicrobial susceptibility testing

Author

Kim, Tae Hyun, Kang, Junwon, Jang, Haewook, Joo, Hyelyn, Lee, Gi Yoon, Kim, Hamin, Cho, Untack, Bang, Hyeeun, Jang, Jisung, Han, Sangkwon, Kim, Dong Young, Lee, Chan Mi, Kang, Chang Kyung, Choe, Pyoeng Gyun, Kim, Nam Joong, Oh, Myoung-don, Kim, Taek Soo, Kim, Inho, Park, Wan Beom, and Kwon, Sunghoon

Published
2024
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2. Baricitinib Treatment of Coronavirus Disease 2019 Is Associated With a Reduction in Secondary Infections

Author

Sweeney, Daniel A, Tuyishimire, Bonifride, Ahuja, Neera, Beigel, John H, Beresnev, Tatiana, Cantos, Valeria D, Castro, Jose G, Cohen, Stuart H, Cross, Kaitlyn, Dodd, Lori E, Erdmann, Nathan, Fung, Monica, Ghazaryan, Varduhi, George, Sarah L, Grimes, Kevin A, Hynes, Noreen A, Julian, Kathleen G, Kandiah, Sheetal, Kim, Hannah Jang, Levine, Corri B, Lindholm, David A, Lye, David C, Maves, Ryan C, Oh, Myoung-Don, Paules, Catharine, Rapaka, Rekha R, Short, Willam R, Tomashek, Kay M, Wolfe, Cameron R, and Kalil, Andre C

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, baricitinib, COVID-19, secondary infections, Clinical sciences, Medical microbiology
Abstract

We performed a secondary analysis of the National Institutes of Health-sponsored Adaptive COVID-19 Treatment Trial (ACTT-2) randomized controlled trial and found that baricitinib was associated with a 50% reduction in secondary infections after controlling for baseline and postrandomization patient characteristics. This finding provides a novel mechanism of benefit for baricitinib and supports the safety profile of this immunomodulator for the treatment of coronavirus disease 2019.

Published
2023

3. Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial.

Author

Wolfe, Cameron R, Tomashek, Kay M, Patterson, Thomas F, Gomez, Carlos A, Marconi, Vincent C, Jain, Mamta K, Yang, Otto O, Paules, Catharine I, Palacios, Guillermo M Ruiz, Grossberg, Robert, Harkins, Michelle S, Mularski, Richard A, Erdmann, Nathaniel, Sandkovsky, Uriel, Almasri, Eyad, Pineda, Justino Regalado, Dretler, Alexandra W, de Castilla, Diego Lopez, Branche, Angela R, Park, Pauline K, Mehta, Aneesh K, Short, William R, McLellan, Susan LF, Kline, Susan, Iovine, Nicole M, El Sahly, Hana M, Doernberg, Sarah B, Oh, Myoung-Don, Huprikar, Nikhil, Hohmann, Elizabeth, Kelley, Colleen F, Holodniy, Mark, Kim, Eu Suk, Sweeney, Daniel A, Finberg, Robert W, Grimes, Kevin A, Maves, Ryan C, Ko, Emily R, Engemann, John J, Taylor, Barbara S, Ponce, Philip O, Larson, LuAnn, Melendez, Dante Paolo, Seibert, Allan M, Rouphael, Nadine G, Strebe, Joslyn, Clark, Jesse L, Julian, Kathleen G, de Leon, Alfredo Ponce, Cardoso, Anabela, de Bono, Stephanie, Atmar, Robert L, Ganesan, Anuradha, Ferreira, Jennifer L, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, Kalil, Andre C, and ACTT-4 Study Group

Subjects
ACTT-4 Study Group, Humans, Oxygen, Sulfonamides, Azetidines, Pyrazoles, Purines, Dexamethasone, Treatment Outcome, Double-Blind Method, Adolescent, Adult, Middle Aged, Female, Male, SARS-CoV-2, COVID-19 Drug Treatment, Clinical Trials and Supportive Activities, Lung, Clinical Research, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

BackgroundBaricitinib and dexamethasone have randomised trials supporting their use for the treatment of patients with COVID-19. We assessed the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to mechanical ventilation or death in hospitalised patients with COVID-19.MethodsIn this randomised, double-blind, double placebo-controlled trial, patients were enrolled at 67 trial sites in the USA (60 sites), South Korea (two sites), Mexico (two sites), Singapore (two sites), and Japan (one site). Hospitalised adults (≥18 years) with COVID-19 who required supplemental oxygen administered by low-flow (≤15 L/min), high-flow (>15 L/min), or non-invasive mechanical ventilation modalities who met the study eligibility criteria (male or non-pregnant female adults ≥18 years old with laboratory-confirmed SARS-CoV-2 infection) were enrolled in the study. Patients were randomly assigned (1:1) to receive either baricitinib, remdesivir, and placebo, or dexamethasone, remdesivir, and placebo using a permuted block design. Randomisation was stratified by study site and baseline ordinal score at enrolment. All patients received remdesivir (≤10 days) and either baricitinib (or matching oral placebo) for a maximum of 14 days or dexamethasone (or matching intravenous placebo) for a maximum of 10 days. The primary outcome was the difference in mechanical ventilation-free survival by day 29 between the two treatment groups in the modified intention-to-treat population. Safety analyses were done in the as-treated population, comprising all participants who received one dose of the study drug. The trial is registered with ClinicalTrials.gov, NCT04640168.FindingsBetween Dec 1, 2020, and April 13, 2021, 1047 patients were assessed for eligibility. 1010 patients were enrolled and randomly assigned, 516 (51%) to baricitinib plus remdesivir plus placebo and 494 (49%) to dexamethasone plus remdesivir plus placebo. The mean age of the patients was 58·3 years (SD 14·0) and 590 (58%) of 1010 patients were male. 588 (58%) of 1010 patients were White, 188 (19%) were Black, 70 (7%) were Asian, and 18 (2%) were American Indian or Alaska Native. 347 (34%) of 1010 patients were Hispanic or Latino. Mechanical ventilation-free survival by day 29 was similar between the study groups (Kaplan-Meier estimates of 87·0% [95% CI 83·7 to 89·6] in the baricitinib plus remdesivir plus placebo group and 87·6% [84·2 to 90·3] in the dexamethasone plus remdesivir plus placebo group; risk difference 0·6 [95% CI -3·6 to 4·8]; p=0·91). The odds ratio for improved status in the dexamethasone plus remdesivir plus placebo group compared with the baricitinib plus remdesivir plus placebo group was 1·01 (95% CI 0·80 to 1·27). At least one adverse event occurred in 149 (30%) of 503 patients in the baricitinib plus remdesivir plus placebo group and 179 (37%) of 482 patients in the dexamethasone plus remdesivir plus placebo group (risk difference 7·5% [1·6 to 13·3]; p=0·014). 21 (4%) of 503 patients in the baricitinib plus remdesivir plus placebo group had at least one treatment-related adverse event versus 49 (10%) of 482 patients in the dexamethasone plus remdesivir plus placebo group (risk difference 6·0% [2·8 to 9·3]; p=0·00041). Severe or life-threatening grade 3 or 4 adverse events occurred in 143 (28%) of 503 patients in the baricitinib plus remdesivir plus placebo group and 174 (36%) of 482 patients in the dexamethasone plus remdesivir plus placebo group (risk difference 7·7% [1·8 to 13·4]; p=0·012).InterpretationIn hospitalised patients with COVID-19 requiring supplemental oxygen by low-flow, high-flow, or non-invasive ventilation, baricitinib plus remdesivir and dexamethasone plus remdesivir resulted in similar mechanical ventilation-free survival by day 29, but dexamethasone was associated with significantly more adverse events, treatment-related adverse events, and severe or life-threatening adverse events. A more individually tailored choice of immunomodulation now appears possible, where side-effect profile, ease of administration, cost, and patient comorbidities can all be considered.FundingNational Institute of Allergy and Infectious Diseases.

Published
2022

4. Immunomodulators for immunocompromised patients hospitalized for COVID-19: a meta-analysis of randomized controlled trials

Author

Hermine, Olivier, Mariette, Xavier, Ravaud, Philippe, Bureau, Serge, Dougados, Maxime, Resche-Rigon, Matthieu, Tharaux, Pierre-Louis, Tibi, Annick, Azoulay, Elie, Cadranel, Jacques, Emmerich, Joseph, Fartoukh, Muriel, Guidet, Bertrand, Humbert, Marc, Lacombe, Karine, Mahevas, Matthieu, Pene, Frédéric, Porcher, Raphaël, Pourchet-Martinez, Valerie, Schlemmer, Frédéric, Yazdanpanah, Yazdan, Baron, Gabriel, Perrodeau, Elodie, Vanhoye, Damien, Kedzia, Cécile, Demerville, Lauren, Gysembergh-Houal, Anne, Bourgoin, Alexandre, Raked, Nabil, Mameri, Lakhdar, Montlahuc, Claire, Biard, Lucie, Alary, St.phanie, Hamiria, Samir, Bariz, Thinhinane, Semri, Hala, Hai, Dhiaa Meriem, Benafla, Moustafa, Belloul, Mohamed, Vauboin, Pernelle, Flamand, Saskia, Pacheco, Claire, Walter-Petrich, Anouk, Stan, Emilia, Benarab, Souad, Nyanou, Corine, Charreteur, Robin, Dupre, Céline, Cardet, Kévin, Lehmann, Blandine, Baghli, Kamyl, Madelaine, Claire, D'Ortenzio, Eric, Puéchal, Oriane, Semaille, Caroline, Savale, Laurent, Harrois, Anatole, Figueiredo, Samy, Duranteau, Jacques, Anguel, Nadia, Pavot, Arthur, Monnet, Xavier, Richard, Christian, Teboul, Jean-Louis, Durand, Philippe, Tissieres, Pierre, Jevnikar, Mitja, Montani, David, Pavy, Stephan, Nocturne, Gaétane, Bitoun, Samuel, Noel, Nicolas, Lambotte, Olivier, Escaut, Lelia, Jauréguiberry, Stephane, Baudry, Elodie, Verny, Christiane, Lefevre, Edouard, Zaidan, Mohamad, Molinari, Domitille, Leprun, Gaël, Fourreau, Alain, Cylly, Laurent, Grimaldi, Lamiae, Virlouvet, Myriam, Meftali, Ramdane, Fabre, Soléne, Licois, Marion, Mamoune, Asmaa, Boudali, Yacine, Le Tiec, Clotilde, Verstuyft, Céline, Roques, Anne-Marie, Georgin-Lavialle, Sophie, Senet, Patricia, Pialoux, Gilles, Soria, Angele, Parrot, Antoine, François, Helene, Rozensztajn, Nathalie, Blin, Emmanuelle, Choinier, Pascaline, Camuset, Juliette, Rech, Jean-Simon, Canellas, Antony, Rolland-Debord, Camille, Lemarié, Nadege, Belaube, Nicolas, Nadal, Marine, Siguier, Martin, Petit-Hoang, Camille, Chas, Julie, Drouet, Elodie, Lemoine, Matthieu, Phibel, Audrey, Aunay, Lucie, Bertrand, Eliane, Ravato, Sylviane, Vayssettes, Marie, Adda, Anne, Wilpotte, Celine, Thibaut, Pélagie, Fillon, Julie, Debrix, Isabelle, Fellahi, Soraya, Bastard, Jean-Philippe, Lefévre, Guillaume, Gottenberg, Jacques-Eric, Hansmann, Yves, Blanc, Frédéric, Ohlmann-Caillard, Sophie, Castelain, Vincent, Chatelus, Emmanuel, Chatron, Eva, Collange, Olivier, Danion, François, De Blay, Frédéric, Diemunsch, Pierre, Diemunsch, Sophie, Felten, Renaud, Goichot, Bernard, Greigert, Valentin, Guffroy, Aurelien, Heger, Bob, Kaeuffer, Charlotte, Kassegne, Loic, Korganow, Anne Sophie, Le Borgne, Pierrick, Lefebvre, Nicolas, Mertes, Paul-Michel, Noll, Eric, Oberlin, Mathieu, Poindron, Vincent, Pottecher, Julien, Ruch, Yvon, Weill, François, Meyer, Nicolas, Andres, Emmanuel, Demonsant, Eric, Tayebi, Hakim, Nisand, Gabriel, Brin, Stéphane, Sublon, Cédric, Becker, Guillaume, Hutt, Anne, Martin, Tristan, Bayer, Sophie, Metzger, Catherine, Mekinian, Arsene, Abisror, Noémie, Adedjouma, Amir, Bollens, Diane, Bonneton, Marion, Bourcicaux, Nathalie, Bourrier, Anne, Thibault Chiarabiani, Maria Chauchard, Chopin, Doroth.e, Cohen, Jonathan, Devred, Ines, Donadille, Bruno, Fain, Olivier, Hariri, Geoffrey, Jachiet, Vincent, Ingliz, Patrick, Garnier, Marc, Gatfosse, Marc, Ghrenassia, Etienne, Gobert, Delphine, Krause le Garrec, Jessica, Landman, Cecilia, Lavillegrand, Jean Remy, Lefebvre, Benedicte, Mahevas, Thibault, Mazerand, Sandie, Meynard, Jean Luc, Morgand, Marjolaine, Ouaz.ne, Zineb, Pacanowski, Jerome, Riviere, S.bastien, Seksik, Philippe, Sokol, Harry, Soliman, Heithem, Valin, Nadia, Urbina, Thomas, McAvoy, Chloé, Miranda, Maria Pereira, Aratus, Gladys, Berard, Laurence, Simon, Tabassome, Nguyen, Anne Daguenel, Girault, Elise, Mayala-Kanda, Cl.mentine, Antignac, Marie, Leplay, Céline, Arlet, Jean-Benoit, Diehl, Jean-Luc, Bellenfant, Florence, Blanchard, Anne, Buffet, Alexandre, Cholley, Bernard, Fayol, Antoine, Flamarion, Edouard, Godier, Anne, Gorget, Thomas, Hamada, Sophie-Rym, Hauw-Berlemont, Caroline, Hulot, Jean-Sébastien, Lebeaux, David, Livrozet, Marine, Michon, Adrien, Neuschwander, Arthur, Pennet, Marie-Aude, Planquette, Benjamin, Ranque, Brigitte, Sanchez, Olivier, Volle, Geoffroy, Briois, Sandrine, Cornic, Mathias, Elisee, Virginie, Denis, Jesuthasan, Djadi-Prat, Juliette, Jouany, Pauline, Junquera, Ramon, Henriques, Mickael, Kebir, Amina, Lehir, Isabelle, Meunier, Jeanne, Patin, Florence, Paquet, Val.rie, Tréhan, Anne, Vigna, Véronique, Sabatier, Brigitte, Bergerot, Damien, Jouve, Charléne, Knosp, Camille, Lenoir, Olivia, Mahtal, Nassim, Resmini, Léa, Lescure, Xavier, Ghosn, Jade, Bachelard, Antoine, Rachline, Anne, Isernia, Valentina, Bao-chau, Phung, Vallois, Dorothée, Sautereau, Aurelie, Neukrich, Catherine, Dossier, Antoine, Borie, Raphaël, Crestani, Bruno, Ducrocq, Gregory, Steg, Philippe Gabriel, Dieude, Philippe, Papo, Thomas, Marcault, Estelle, Chaudhry, Marhaba, Da Silveira, Charléne, Metois, Annabelle, Mahenni, Ismahan, Meziani, Meriam, Nilusmas, Cyndie, Le Gac, Sylvie, Ndiaye, Awa, Louni, Fran.oise, Chansombat, Malikhone, Julia, Zelie, Chalal, Solaya, Chalal, Lynda, Kramer, Laura, Le Grand, Jeniffer, Ouifiya, Kafif, Piquard, Valentine, Tubiana, Sarah, Nguyen, Yann, Honsel, Vasco, Weiss, Emmanuel, Codorniu, Anais, Zarrouk, Virginie, de Lastours, Victoire, Uzzan, Matthieu, Gamany, Naura, Claveirole, Agathe, Navid, Alexandre, Fouque, Tiffanie, Cohen, Yonathan, Lupo, Maya, Gilles, Constance, Rahli, Roza, Louis, Zeina, Boutboul, David, Galicier, Lionel, Amara, Yaël, Archer, Gabrielle, Benattia, Amira, Bergeron, Anne, Bondeelle, Louise, de Castro, Nathalie, Clément, Melissa, Darmon, Michaël, Denis, Blandine, Dupin, Clairelyne, Feredj, Elsa, Feyeux, Delphine, Joseph, Adrien, Lenglin, Etienne, Le Guen, Pierre, Liégeon, Geoffroy, Lorillon, Gwenaël, Mabrouki, Asma, Mariotte, Eric, Martin de Frémont, Grégoire, Mirouse, Adrien, Molina, Jean-Michel, Peffault de Latour, Régis, Oksenhendler, Eric, Saussereau, Julien, Tazi, Abdellatif, Tudesq, Jean-Jacques, Zafrani, Lara, Brindele, Isabelle, Bugnet, Emmanuelle, Lebras, Karine Celli, Chabert, Julien, Djaghout, Lamia, Fauvaux, Catherine, Jegu, Anne Lise, Kozakiewicz, Ewa, Meunier, Martine, Tremorin, Marie-Thérèse, Davoine, Claire, Madelaine, Isabelle, Caillat-Zucman, Sophie, Delaugerre, Constance, Morin, Florence, Sène, Damien, Burlacu, Ruxandra, Chousterman, Benjamin, Mégarbanne, Bruno, Richette, Pascal, Riveline, Jean-Pierre, Frazier, Aline, Vicaut, Eric, Berton, Laure, Hadjam, Tassadit, Vazquez-Ibarra, Miguel Alejandro, Jourdaine, Clément, Tran, Olivia, Jouis, Véronique, Jacob, Aude, Smati, Julie, Renaud, Stéphane, Pernin, Claire, Suarez, Lydia, Semerano, Luca, Abad, Sébastien, nainous, Ruben B., Bonnet, Nicolas, Comparon, Celine, Cohen, Yves, Cordel, Hugues, Dhote, Robin, Dournon, Nathalie, Duchemann, Boris, Ebstein, Nathan, Gille, Thomas, Giroux-Leprieur, Benedicte, Goupil de Bouille, Jeanne, Nunes, Hilario, Oziel, Johanna, Roulot, Dominique, Sese, Lucile, ClaireTantet, Uzunhan, Yurdagul, Bloch-Queyrat, Coralie, Levy, Vincent, Messani, Fadhila, Rahaoui, Mohammed, Petit, Myléne, Brahmi, Sabrina, Rathoin, Vanessa, Rigal, Marthe, Costedoat-Chalumeau, Nathalie, Luong, Liem Binh, Hamou, Zakaria Ait, Benghanem, Sarah, Blanche, Philippe, Carlier, Nicolas, Chaigne, Benjamin, Gauzit, Remy, Joumaa, Hassan, Jozwiak, Mathieu, Lachétre, Marie, Lafoeste, Hélène, Launay, Odie, Legendre, Paul, Marey, Jonathan, Morbieu, Caroline, Palmieri, Lola-Jade, Szwebel, Tali-Anne, Abdoul, Hendy, Bruneau, Alexandra, Beclin-Clabaux, Audrey, Larrieu, Charly, Montanari, Pierre, Dufour, Eric, Clarke, Ada, Le Bourlout, Catherine, Marin, Nathalie, Menage, Nathalie, Saleh-Mghir, Samira, Cisse, Mamadou Salif, Cheref, Kahina, Guerin, Corinne, Zerbit, Jérémie, Michel, Marc, Gallien, Sébastien, Crickx, Etienne, Le Vavasseur, Benjamin, Kempf, Emmanuelle, Jaffal, Karim, Vindrios, William, Oniszczuk, Julie, Guillaud, Constance, Lim, Pascal, Fois, Elena, Melica, Giovanna, Matignon, Marie, Jalabert, Maud, Lelièvre, Jean-Daniel, Schmitz, David, Bourhis, Marion, Belazouz, Sylia, Languille, Laetitia, Boucle, Caroline, Cita, Nelly, Didier, Agnés, Froura, Fahem, Ledudal, Katia, Sadaoui, Thiziri, Thiemele, Alaki, Le Febvre De Bailly, Delphine, Verlinde, Muriel Carvhalo, Mayaux, Julien, Cacoub, Patrice, Saadoun, David, Vautier, Mathieu, Bugaut, Héléne, Benveniste, Olivier, Allenbach, Yves, Leroux, Gaëlle, Rigolet, Aude, Guillaume-Jugnot, Perrine, Domont, Fanny, Desbois, Anne Claire, Comarmond, Chloé, Champtiaux, Nicolas, Toquet, Segolene, Ghembaza, Amine, Vieira, Matheus, Maalouf, Georgina, Boleto, Goncalo, Ferfar, Yasmina, Corvol, Jean-Christophe, Louapre, C.line, Sambin, Sara, Mariani, Louise-Laure, Karachi, Carine, Tubach, Florence, Estellat, Candice, Gimeno, Linda, Martin, Karine, Bah, Aicha, Keo, Vixra, Ouamri, Sabrine, Messaoudi, Yasmine, Yelles, Nessima, Faye, Pierre, Cavelot, Sebastien, Larcheveque, Cecile, Annonay, Laurence, Benhida, Jaouad, Zahrate-Ghoul, Aida, Hammal, Soumeya, Belilita, Ridha, Charbonnier, Fanny, Aguilar, Claire, Alby-Laurent, Fanny, Burger, Carole, Campos-Vega, Clara, Chavarot, Nathalie, Fournier, Benjamin, Rouzaud, Claire, Vimpére, Damien, Elie, Caroline, Bakouboula, Prissile, Choupeaux, Laure, Granville, Sophie, Issorat, Elodie, Broissand, Christine, Alyanakian, Marie-Alexandra, Geri, Guillaume, Derridj, Nawal, Sguiouar, Naima, Meddah, Hakim, Djadel, Mourad, Chambrin-Lauvray, Héléne, Duclos-vallée, Jean-Charles, Saliba, Faouzi, Sacleux, Sophie-Caroline, Kounis, Ilias, Tamazirt, Sonia, Rudant, Eric, Michot, Jean-Marie, Stoclin, Annabelle, Colomba, Emeline, Pommeret, Fanny, Willekens, Christophe, Da Silva, Rosa, Dejean, Valérie, Mekid, Yasmina, Ben-Mabrouk, Ines, Netzer, Florence, Pradon, Caroline, Drouard, Laurence, Camara-Clayette, Valérie, Morel, Alexandre, Garcia, Gilles, Mohebbi, Abolfazl, Berbour, Férial, Dehais, Mélanie, Pouliquen, Anne-Lise, Klasen, Alison, Soyez-Herkert, Loren, London, Jonathan, Keroumi, Younes, Guillot, Emmanuelle, Grailles, Guillaume, El amine, Younes, Defrancq, Fanny, Fodil, Hanane, Bouras, Chaouki, Dautel, Dominique, Gambier, Nicolas, Dieye, Thierno, Bienvenu, Boris, Lancon, Victor, Lecomte, Laurence, Beziriganyan, Kristina, Asselate, Belkacem, Allanic, Laure, Kiouris, Elena, Legros, Marie-Héléne, Lemagner, Christine, Martel, Pascal, Provitolo, Vincent, Ackermann, Félix, Le Marchand, Mathilde, Chan Hew Wai, Aurélie, Fremont, Dimitri, Coupez, Elisabeth, Adda, Mireille, Duée, Frédéric, Bernard, Lise, Gros, Antoine, Henry, Estelle, Courtin, Claire, Pattyn, Anne, Guinot, Pierre-Grégoire, Bardou, Marc, Maurer, Agnes, Jambon, Julie, Cransac, Amélie, Pernot, Corinne, Mourvillier, Bruno, Marquis, Eric, Benoit, Philippe, Roux, Damien, Gernez, Coralie, Yelnik, Cécile, Poissy, Julien, Nizard, Mandy, Denies, Fanette, Gros, Helene, Mourad, Jean-Jacques, Sacco, Emmanuelle, Renet, Sophie, Ader, F., Yazdanpanah, Y., Mentre, F., Peiffer-Smadja, N., Lescure, F.X., Poissy, J., Bouadma, L., Timsit, J.F., Lina, B., Morfin-Sherpa, F., Bouscambert, M., Gaymard, A., Peytavin, G., Abel, L., Guedj, J., Andrejak, C., Burdet, C., Laouenan, C., Belhadi, D., Dupont, A., Alfaiate, T., Basli, B., Chair, A., Laribi, S., Level, J., Schneider, M., Tellier, M.C., Dechanet, A., Costagliola, D., Terrier, B., Ohana, M., Couffin-Cadiergues, S., Esperou, H., Delmas, C., Saillard, J., Fougerou, C., Moinot, L., Wittkop, L., Cagnot, C., Le Mestre, S., Lebrasseur-Longuet, D., Petrov-Sanchez, V., Diallo, A., Mercier, N., Icard, V., Leveau, B., Tubiana, S., Hamze, B., Gelley, A., Noret, M., D’Ortenzio, E., Puechal, O., Semaille, C., Welte, T., Paiva, J.A., Halanova, M., Kieny, M.P., Balssa, E., Birkle, C., Gibowski, S., Landry, E., Le Goff, A., Moachon, L., Moins, C., Wadouachi, L., Paul, C., Levier, A., Bougon, D., Djossou, F., Epelboin, L., Dellamonica, J., Marquette, C.H., Robert, C., Gibot, S., Senneville, E., Jean-Michel, V., Zerbib, Y., Chirouze, C., Boyer, A., Cazanave, C., Gruson, D., Malvy, D., Andreu, P., Quenot, J.P., Terzi, N., Faure, K., Chabartier, C., Le Moing, V., Klouche, K., Ferry, T., F, Valour, Gaborit, B., Canet, E., Le Turnier, P., Boutoille, D., Bani-Sadr, F., Benezit, F., Revest, M., Cameli, C., Caro, A., Um Tegue, MJ Ngo, Le Tulzo, Y., Laviolle, B., Laine, F., Thiery, G., Meziani, F., Hansmann, Y., Oulehri, W., Tacquard, C., Vardon-Bounes, F., Riu-Poulenc, B., Murris-Espin, M., Bernard, L., Garot, D., Hinschberger, O., Martinot, M., Bruel, C., Pilmis, B., Bouchaud, O., Loubet, P., Roger, C., Monnet, X., Figueiredo, S., Godard, V., Mira, J.P., Lachatre, M., Kerneis, S., Aboab, J., Sayre, N., Crockett, F., Lebeaux, D., Buffet, A., Diehl, J.L., Fayol, A., Hulot, J.S., Livrozet, M., Dessap, A Mekontso, Ficko, C., Stefan, F., Le Pavec, J., Mayaux, J., Ait-Oufella, H., Molina, J.M., Pialoux, G., Fartoukh, M., Textoris, J., Brossard, M., Essat, A., Netzer, E., Riault, Y., Ghislain, M., Beniguel, L., Genin, M., Gouichiche, L., Betard, C., Belkhir, L., Altdorfer, A., Centro, V Fraipont, Braz, S., Ribeiro, JM Ferreira, Alburqueque, R Roncon, Berna, M., Alexandre, M., Lamprecht, B., Egle, A., Greil, R., Joannidis, M., Patterson, Thomas F., Ponce, Philip O., Taylor, Barbara S., Patterson, Jan E., Bowling, Jason E., Javeri, Heta, Kalil, Andre C., Larson, LuAnn, Hewlett, Angela, Mehta, Aneesh K., Rouphael, Nadine G., Saklawi, Youssef, Scanlon, Nicholas, Traenkner, Jessica J., Trible, Ronald P., Jr., Walter, Emmanuel B., Ivey, Noel, Holland, Thomas L., Ruiz-Palacios, Guillermo M., Ponce de León, Alfredo, Rajme, Sandra, Hsieh, Lanny, Amin, Alpesh N., Watanabe, Miki, Lee, Helen S., Kline, Susan, Billings, Joanne, Noren, Brooke, Kim, Hyun, Bold, Tyler D., Tapson, Victor, Grein, Jonathan, Sutterwala, Fayyaz, Iovine, Nicole, Beattie, Lars K., Wakeman, Rebecca Murray, Shaw, Matthew, Jain, Mamta K., Mocherla, Satish, Meisner, Jessica, Luque, Amneris, Sweeney, Daniel A., Benson, Constance A., Ali, Farhana, Atmar, Robert L., El Sahly, Hana M., Whitaker, Jennifer, Falsey, Ann R., Branche, Angela R., Rozario, Cheryl, Pineda, Justino Regalado, Martinez-Orozco, José Arturo, Lye, David Chien, Ong, Sean WX., Chia, Po Ying, Young, Barnaby E., Sandkovsky, Uriel, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Cantos, Valeria D., Kelley, Colleen F., Rebolledo Esteinou, Paulina A., Kandiah, Sheetal, Doernberg, Sarah B., Crouch, Pierre-Cedric B., Jang, Hannah, Luetkemeyer, Anne F., Dwyer, Jay, Cohen, Stuart H., Thompson, George R., 3rd, Nguyen, Hien H., Finberg, Robert W., Wang, Jennifer P., Perez-Velazquez, Juan, Wessolossky, Mireya, Jackson, Patrick E.H., Bell, Taison D., West, Miranda J., Taiwo, Babafemi, Krueger, Karen, Perez, Johnny, Pearson, Triniece, Paules, Catharine I., Julian, Kathleen G., Ahmad, Danish, Hajduczok, Alexander G., Arguinchona, Henry, Arguinchona, Christa, Erdmann, Nathaniel, Goepfert, Paul, Ahuja, Neera, Frank, Maria G., Wyles, David, Young, Heather, Oh, Myoung-don, Park, Wan Beom, Kang, Chang Kyung, Marconi, Vincent, Moanna, Abeer, Cribbs, Sushma, Harrison, Telisha, Kim, Eu Suk, Jung, Jongtak, Song, Kyoung-Ho, Kim, Hong Bin, Tan, Seow Yen, Shafi, Humaira, Chien, Jaime, Fong, Raymond KC., Murray, Daniel D., Lundgren, Jens, Nielsen, Henrik, Jensen, Tomas, Zingman, Barry S., Grossberg, Robert, Riska, Paul F., Yang, Otto O., Ahn, Jenny, Arias, Rubi, Rapaka, Rekha R., Hauser, Naomi, Campbell, James D., Short, William R., Tebas, Pablo, Baron, Jillian T., McLellan, Susan L.F., Blanton, Lucas S., Seashore, Justin B., Creech, C. Buddy, Rice, Todd W., Walker, Shannon, Thomsen, Isaac P., Lopez de Castilla, Diego, Van Winkle, Jason W., Riedo, Francis X., Pada, Surinder Kaur, Wang, Alvin DY., Lin, Li, Harkins, Michelle, Mertz, Gregory, Sosa, Nestor, Ann Chai, Louis Yi, Tambyah, Paul Anantharajah, Tham, Sai Meng, Archuleta, Sophia, Yan, Gabriel, Lindholm, David A., Markelz, Ana Elizabeth, Mende, Katrin, Mularski, Richard, Hohmann, Elizabeth, Torres-Soto, Mariam, Jilg, Nikolaus, Maves, Ryan C., Utz, Gregory C., George, Sarah L., Hoft, Daniel F., Brien, James D., Paredes, Roger, Mateu, Lourdes, Loste, Cora, Kumar, Princy, Thornton, Sarah, Mohanraj, Sharmila, Hynes, Noreen A., Sauer, Lauren M., Colombo, Christopher J., Schofield, Christina, Colombo, Rhonda E., Chambers, Susan E., Novak, Richard M., Wendrow, Andrea, Gupta, Samir K., Lee, Tida, Lalani, Tahaniyat, Holodniy, Mark, Chary, Aarthi, Huprikar, Nikhil, Ganesan, Anuradha, Ohmagari, Norio, Mikami, Ayako, Price, D. Ashley, Duncan, Christopher J.A., Dierberg, Kerry, Neumann, Henry J., Taylor, Stephanie N., Lacour, Alisha, Masri, Najy, Swiatlo, Edwin, Widmer, Kyle, Neaton, James D., Bessesen, Mary, Stephens, David S., Burgess, Timothy H., Uyeki, Timothy M., Walker, Robert, Marks, G. Lynn, Osinusi, Anu, Cao, Huyen, Cardoso, Anabela, de Bono, Stephanie, Schlichting, Douglas E., Chung, Kevin K., Ferreira, Jennifer L., Green, Michelle, Makowski, Mat, Wierzbicki, Michael R., Conrad, Tom M., El-Khorazaty, Jill Ann, Hill, Heather, Bonnett, Tyler, Gettinger, Nikki, Engel, Theresa, Lewis, Teri, Wang, Jing, Beigel, John H., Tomashek, Kay M., Ghazaryan, Varduhi, Beresnev, Tatiana, Nayak, Seema, Dodd, Lori E., Dempsey, Walla, Nomicos, Effie, Lee, Marina, Pikaart-Tautges, Rhonda, Elsafy, Mohamed, Jurao, Robert, Koo, Hyung, Proschan, Michael, Yokum, Tammy, Arega, Janice, Florese, Ruth, Voell, Jocelyn D., Davey, Richard, Serrano, Ruth C., Wiley, Zanthia, Phadke, Varun K., Goepfert, Paul A., Gomez, Carlos A., Sofarelli, Theresa A., Certain, Laura, Imlay, Hannah N., Wolfe, Cameron R., Ko, Emily R., Engemann, John J., Felix, Nora Bautista, Wan, Claire R., Elmor, Sammy T., Bristow, Laurel R., Harkins, Michelle S., Iovine, Nicole M., Elie-Turenne, Marie-Carmelle, Tapson, Victor F., Choe, Pyoeng Gyun, Mularski, Richard A., Rhie, Kevin S., Hussein, Rezhan H., Ince, Dilek, Winokur, Patricia L., Takasaki, Jin, Saito, Sho, McConnell, Kimberly, Wyles, David L., Sarcone, Ellen, Grimes, Kevin A., Perez, Katherine, Janak, Charles, Whitaker, Jennifer A., Rebolledo, Paulina A., Gharbin, John, Lambert, Allison A., Zea, Diego F., Bainbridge, Emma, Hostler, David C., Hostler, Jordanna M., Shahan, Brian T., Ling, Evelyn, Go, Minjoung, Hubbard, Fleesie A., Chakrabarty, Melony, Laguio-Vila, Maryrose, Walsh, Edward E., Guirgis, Faheem, Marconi, Vincent C., Madar, Christian, Borgetti, Scott A., Levine, Corri, Nock, Joy, Candiotti, Keith, Rozman, Julia, Dangond, Fernando, Hyvert, Yann, Seitzinger, Andrea, Cross, Kaitlyn, Pettibone, Stephanie, Nayak, Seema U., Deye, Gregory A., Siempos, Ilias I., Belhadi, Drifa, Veiga, Viviane Cordeiro, Cavalcanti, Alexandre Biasi, Branch-Elliman, Westyn, Papoutsi, Eleni, Gkirgkiris, Konstantinos, Xixi, Nikoleta A., and Kotanidou, Anastasia

Published
2024
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5. Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial

Author

Kalil, Andre C, Mehta, Aneesh K, Patterson, Thomas F, Erdmann, Nathaniel, Gomez, Carlos A, Jain, Mamta K, Wolfe, Cameron R, Ruiz-Palacios, Guillermo M, Kline, Susan, Pineda, Justino Regalado, Luetkemeyer, Anne F, Harkins, Michelle S, Jackson, Patrick EH, Iovine, Nicole M, Tapson, Victor F, Oh, Myoung-don, Whitaker, Jennifer A, Mularski, Richard A, Paules, Catharine I, Ince, Dilek, Takasaki, Jin, Sweeney, Daniel A, Sandkovsky, Uriel, Wyles, David L, Hohmann, Elizabeth, Grimes, Kevin A, Grossberg, Robert, Laguio-Vila, Maryrose, Lambert, Allison A, de Castilla, Diego Lopez, Kim, EuSuk, Larson, LuAnn, Wan, Claire R, Traenkner, Jessica J, Ponce, Philip O, Patterson, Jan E, Goepfert, Paul A, Sofarelli, Theresa A, Mocherla, Satish, Ko, Emily R, de Leon, Alfredo Ponce, Doernberg, Sarah B, Atmar, Robert L, Maves, Ryan C, Dangond, Fernando, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori, Tomashek, Kay M, Beigel, John H, members, ACTT-3 study group, Hewlett, Angela, Taylor, Barbara S, Bowling, Jason E, Serrano, Ruth C, Rouphael, Nadine G, Wiley, Zanthia, Phadke, Varun K, Certain, Laura, Imlay, Hannah N, Engemann, John J, Walter, Emmanuel B, Meisner, Jessica, Rajme, Sandra, Billings, Joanne, Kim, Hyun, Martinez-Orozco, Jose A, Felix, Nora Bautista, Elmor, Sammy T, Bristow, Laurel R, Mertz, Gregory, Sosa, Nestor, Bell, Taison D, West, Miranda J, Elie-Turenne, Marie-Carmelle, Grein, Jonathan, Sutterwala, Fayyaz, Choe, Pyoeng Gyun, Kang, Chang Kyung, Sahly, Hana M El, Rhie, Kevin S, Hussein, Rezhan H, Winokur, Patricia L, Mikami, Ayako, Saito, Sho, Benson, Constance A, McConnell, Kimberly, Berhe, Mezgebe, Dishner, Emma, Frank, Maria G, Sarcone, Ellen, Crouch, Pierre-Cedric B, Jang, Hannah, and Jilg, Nikolaus

Subjects
Rehabilitation, Clinical Trials and Supportive Activities, Lung, Clinical Research, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Adenosine Monophosphate, Adult, Aged, Alanine, Antiviral Agents, Double-Blind Method, Female, Humans, Interferon beta-1a, Japan, Male, Mexico, Middle Aged, Oxygen, Oxygen Saturation, Republic of Korea, SARS-CoV-2, Singapore, Treatment Outcome, United States, COVID-19 Drug Treatment, ACTT-3 study group members, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

BackgroundFunctional impairment of interferon, a natural antiviral component of the immune system, is associated with the pathogenesis and severity of COVID-19. We aimed to compare the efficacy of interferon beta-1a in combination with remdesivir compared with remdesivir alone in hospitalised patients with COVID-19.MethodsWe did a double-blind, randomised, placebo-controlled trial at 63 hospitals across five countries (Japan, Mexico, Singapore, South Korea, and the USA). Eligible patients were hospitalised adults (aged ≥18 years) with SARS-CoV-2 infection, as confirmed by a positive RT-PCR test, and who met one of the following criteria suggestive of lower respiratory tract infection: the presence of radiographic infiltrates on imaging, a peripheral oxygen saturation on room air of 94% or less, or requiring supplemental oxygen. Patients were excluded if they had either an alanine aminotransferase or an aspartate aminotransferase concentration more than five times the upper limit of normal; had impaired renal function; were allergic to the study product; were pregnant or breast feeding; were already on mechanical ventilation; or were anticipating discharge from the hospital or transfer to another hospital within 72 h of enrolment. Patients were randomly assigned (1:1) to receive intravenous remdesivir as a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose administered daily for up to 9 days and up to four doses of either 44 μg interferon beta-1a (interferon beta-1a group plus remdesivir group) or placebo (placebo plus remdesivir group) administered subcutaneously every other day. Randomisation was stratified by study site and disease severity at enrolment. Patients, investigators, and site staff were masked to interferon beta-1a and placebo treatment; remdesivir treatment was given to all patients without masking. The primary outcome was time to recovery, defined as the first day that a patient attained a category 1, 2, or 3 score on the eight-category ordinal scale within 28 days, assessed in the modified intention-to-treat population, defined as all randomised patients who were classified according to actual clinical severity. Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04492475.FindingsBetween Aug 5, 2020, and Nov 11, 2020, 969 patients were enrolled and randomly assigned to the interferon beta-1a plus remdesivir group (n=487) or to the placebo plus remdesivir group (n=482). The mean duration of symptoms before enrolment was 8·7 days (SD 4·4) in the interferon beta-1a plus remdesivir group and 8·5 days (SD 4·3) days in the placebo plus remdesivir group. Patients in both groups had a time to recovery of 5 days (95% CI not estimable) (rate ratio of interferon beta-1a plus remdesivir group vs placebo plus remdesivir 0·99 [95% CI 0·87-1·13]; p=0·88). The Kaplan-Meier estimate of mortality at 28 days was 5% (95% CI 3-7%) in the interferon beta-1a plus remdesivir group and 3% (2-6%) in the placebo plus remdesivir group (hazard ratio 1·33 [95% CI 0·69-2·55]; p=0·39). Patients who did not require high-flow oxygen at baseline were more likely to have at least one related adverse event in the interferon beta-1a plus remdesivir group (33 [7%] of 442 patients) than in the placebo plus remdesivir group (15 [3%] of 435). In patients who required high-flow oxygen at baseline, 24 (69%) of 35 had an adverse event and 21 (60%) had a serious adverse event in the interferon beta-1a plus remdesivir group compared with 13 (39%) of 33 who had an adverse event and eight (24%) who had a serious adverse event in the placebo plus remdesivir group.InterpretationInterferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo.FundingThe National Institute of Allergy and Infectious Diseases (USA).

Published
2021

7. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Author

Kalil, Andre C, Patterson, Thomas F, Mehta, Aneesh K, Tomashek, Kay M, Wolfe, Cameron R, Ghazaryan, Varduhi, Marconi, Vincent C, Ruiz-Palacios, Guillermo M, Hsieh, Lanny, Kline, Susan, Tapson, Victor, Iovine, Nicole M, Jain, Mamta K, Sweeney, Daniel A, El Sahly, Hana M, Branche, Angela R, Regalado Pineda, Justino, Lye, David C, Sandkovsky, Uriel, Luetkemeyer, Anne F, Cohen, Stuart H, Finberg, Robert W, Jackson, Patrick EH, Taiwo, Babafemi, Paules, Catharine I, Arguinchona, Henry, Erdmann, Nathaniel, Ahuja, Neera, Frank, Maria, Oh, Myoung-Don, Kim, Eu-Suk, Tan, Seow Y, Mularski, Richard A, Nielsen, Henrik, Ponce, Philip O, Taylor, Barbara S, Larson, LuAnn, Rouphael, Nadine G, Saklawi, Youssef, Cantos, Valeria D, Ko, Emily R, Engemann, John J, Amin, Alpesh N, Watanabe, Miki, Billings, Joanne, Elie, Marie-Carmelle, Davey, Richard T, Burgess, Timothy H, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Cardoso, Anabela, de Bono, Stephanie, Bonnett, Tyler, Proschan, Michael, Deye, Gregory A, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, and Beigel, John H

Subjects
Rehabilitation, Clinical Trials and Supportive Activities, Lung, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adenosine Monophosphate, Adult, Aged, Alanine, Antiviral Agents, Azetidines, COVID-19, Double-Blind Method, Drug Therapy, Combination, Female, Hospital Mortality, Hospitalization, Humans, Janus Kinase Inhibitors, Male, Middle Aged, Oxygen Inhalation Therapy, Purines, Pyrazoles, Respiration, Artificial, Sulfonamides, Treatment Outcome, COVID-19 Drug Treatment, ACTT-2 Study Group Members, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundSevere coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.MethodsWe conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.ResultsA total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).ConclusionsBaricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).

Published
2021

9. Remdesivir for the Treatment of Covid-19 — Final Report

Author

Beigel, John H, Tomashek, Kay M, Dodd, Lori E, Mehta, Aneesh K, Zingman, Barry S, Kalil, Andre C, Hohmann, Elizabeth, Chu, Helen Y, Luetkemeyer, Annie, Kline, Susan, Lopez de Castilla, Diego, Finberg, Robert W, Dierberg, Kerry, Tapson, Victor, Hsieh, Lanny, Patterson, Thomas F, Paredes, Roger, Sweeney, Daniel A, Short, William R, Touloumi, Giota, Lye, David Chien, Ohmagari, Norio, Oh, Myoung-Don, Ruiz-Palacios, Guillermo M, Benfield, Thomas, Fätkenheuer, Gerd, Kortepeter, Mark G, Atmar, Robert L, Creech, C Buddy, Lundgren, Jens, Babiker, Abdel G, Pett, Sarah, Neaton, James D, Burgess, Timothy H, Bonnett, Tyler, Green, Michelle, Makowski, Mat, Osinusi, Anu, Nayak, Seema, and Lane, H Clifford

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Clinical Trials and Supportive Activities, Clinical Research, Rehabilitation, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Adenosine Monophosphate, Administration, Intravenous, Adult, Aged, Alanine, Antiviral Agents, Betacoronavirus, COVID-19, Coronavirus Infections, Double-Blind Method, Extracorporeal Membrane Oxygenation, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Oxygen Inhalation Therapy, Pandemics, Pneumonia, Viral, Respiration, Artificial, SARS-CoV-2, Time Factors, Young Adult, COVID-19 Drug Treatment, ACTT-1 Study Group Members, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAlthough several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.MethodsWe conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.ResultsA total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P

Published
2020

10. A minimal common outcome measure set for COVID-19 clinical research

Author

infection, WHO Working Group on the Clinical Characterisation and Management of COVID-19, Marshall, John C, Murthy, Srinivas, Diaz, Janet, Adhikari, NK, Angus, Derek C, Arabi, Yaseen M, Baillie, Kenneth, Bauer, Michael, Berry, Scott, Blackwood, Bronagh, Bonten, Marc, Bozza, Fernando, Brunkhorst, Frank, Cheng, Allen, Clarke, Mike, Dat, Vu Quoc, de Jong, Menno, Denholm, Justin, Derde, Lennie, Dunning, Jake, Feng, Xiaobin, Fletcher, Tom, Foster, Nadine, Fowler, Rob, Gobat, Nina, Gomersall, Charles, Gordon, Anthony, Glueck, Thomas, Harhay, Michael, Hodgson, Carol, Horby, Peter, Kim, YaeJean, Kojan, Richard, Kumar, Bharath, Laffey, John, Malvey, Denis, Martin-Loeches, Ignacio, McArthur, Colin, McAuley, Danny, McBride, Stephen, McGuinness, Shay, Merson, Laura, Morpeth, Susan, Needham, Dale, Netea, Mihai, Oh, Myoung-Don, Phyu, Sabai, Piva, Simone, Qiu, Ruijin, Salisu-Kabara, Halima, Shi, Lei, Shimizu, Naoki, Sinclair, Jorge, Tong, Steven, Turgeon, Alexis, Uyeki, Tim, van de Veerdonk, Frank, Webb, Steve, Williamson, Paula, Wolf, Timo, and Zhang, Junhua

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Rare Diseases, Infectious Diseases, Infection, Good Health and Well Being, Betacoronavirus, COVID-19, Clinical Trials as Topic, Coronavirus Infections, Humans, Outcome Assessment, Health Care, Pandemics, Patient Outcome Assessment, Pneumonia, Viral, SARS-CoV-2, Survival Analysis, Treatment Outcome, Viral Load, WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection, Medical Microbiology, Public Health and Health Services, Microbiology, Clinical sciences, Medical microbiology, Epidemiology
Abstract

Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.

Published
2020

11. Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial

Author

Wahid, Lana, Walter, Emmanuel B., Belur, Akhila G., Dreyer, Grace, Patterson, Jan E., Bowling, Jason E., Dixon, Danielle O., Hewlett, Angela, Odrobina, Robert, Pupaibool, Jakrapun, Mocherla, Satish, Lazarte, Suzana, Cayabyab, Meilani, Hussein, Rezhan H., Golamari, Reshma R., Krill, Kaleigh L., Rajme, Sandra, Riska, Paul F., Zingman, Barry S., Mertz, Gregory, Sosa, Nestor, Goepfert, Paul A., Berhe, Mezgebe, Dishner, Emma, Fayed, Mohamed, Hubel, Kinsley, Martinez-Orozco, José Arturo, Bautista Felix, Nora, Elmor, Sammy T., Bechnak, Amer Ryan, Saklawi, Youssef, Van Winkle, Jason W., Zea, Diego F., Laguio-Vila, Maryrose, Walsh, Edward E., Falsey, Ann R., Carvajal, Karen, Hyzy, Robert C., Hanna, Sinan, Olbrich, Norman, Traenkner, Jessica J., Kraft, Colleen S., Tebas, Pablo, Baron, Jillian T, Levine, Corri, Nock, Joy, Billings, Joanne, Kim, Hyun, Elie-Turenne, Marie-Carmelle, Whitaker, Jennifer A., Luetkemeyer, Anne F., Dwyer, Jay, Bainbridge, Emma, Gyun Choe, Pyoeng, Kyung Kang, Chang, Jilg, Nikolaus, Cantos, Valeria D, Bhamidipati, Divya R., Nithin Gopalsamy, Srinivasa, Chary, Aarthi, Jung, Jongtak, Song, Kyoung-Ho, Kim, Hong Bin, Benson, Constance A., McConnell, Kimberly, Wang, Jennifer P., Wessolossky, Mireya, Perez, Katherine, Eubank, Taryn A, Berjohn, Catherine, Utz, Gregory C., Jackson, Patrick E.H., Bell, Taison D., Haughey, Heather M., Moanna, Abeer, Cribbs, Sushma, Harrison, Telisha, Colombo, Christopher J., Schofield, Christina, Colombo, Rhonda E., Tapson, Victor F., Grein, Jonathan, Sutterwala, Fayyaz, Ince, Dilek, Winokur, Patricia L., Fung, Monica, Jang, Hannah, Wyles, David, Frank, Maria G., Sarcone, Ellen, Neumann, Henry, Viswanathan, Anand, Hochman, Sarah, Mulligan, Mark, Eckhardt, Benjamin, Carmody, Ellie, Ahuja, Neera, Nadeau, Kari, Svec, David, Macaraeg, Jeffrey C., Morrow, Lee, Quimby, Dave, Bessesen, Mary, Nicholson, Lindsay, Adams, Jill, Kumar, Princy, Lambert, Allison A., Arguinchona, Henry, Alicic, Radica Z., Saito, Sho, Ohmagari, Norio, Mikami, Ayako, Chien Lye, David, Hong Lee, Tau, Ying Chia, Po, Hsieh, Lanny, Amin, Alpesh N., Watanabe, Miki, Candiotti, Keith A., Castro, Jose G., Antor, Maria A., Lee, Tida, Lalani, Tahaniyat, Novak, Richard M., Wendrow, Andrea, Borgetti, Scott A., George, Sarah L., Hoft, Daniel F., Brien, James D., Cohen, Stuart H., Thompson, George R., 3rd, Chakrabarty, Melony, Guirgis, Faheem, Davey, Richard T., Voell, Jocelyn, Strich, Jeffrey R., Lindholm, David A., Mende, Katrin, Wellington, Trevor R., Rapaka, Rekha R., Husson, Jennifer S., Levine, Andrea R., Yen Tan, Seow, Shafi, Humaira, Chien, Jaime M F, Hostler, David C., Hostler, Jordanna M., Shahan, Brian T., Adams, David H., Osinusi, Anu, Cao, Huyen, Burgess, Timothy H., Rozman, Julia, Chung, Kevin K., Nieuwoudt, Christina, El-Khorazaty, Jill A., Hill, Heather, Pettibone, Stephanie, Gettinger, Nikki, Engel, Theresa, Lewis, Teri, Wang, Jing, Deye, Gregory A., Nomicos, Effie, Pikaart-Tautges, Rhonda, Elsafy, Mohamed, Jurao, Robert, Koo, Hyung, Proschan, Michael, Yokum, Tammy, Arega, Janice, Florese, Ruth, Wolfe, Cameron R, Tomashek, Kay M, Patterson, Thomas F, Gomez, Carlos A, Marconi, Vincent C, Jain, Mamta K, Yang, Otto O, Paules, Catharine I, Palacios, Guillermo M Ruiz, Grossberg, Robert, Harkins, Michelle S, Mularski, Richard A, Erdmann, Nathaniel, Sandkovsky, Uriel, Almasri, Eyad, Pineda, Justino Regalado, Dretler, Alexandra W, de Castilla, Diego Lopez, Branche, Angela R, Park, Pauline K, Mehta, Aneesh K, Short, William R, McLellan, Susan L F, Kline, Susan, Iovine, Nicole M, El Sahly, Hana M, Doernberg, Sarah B, Oh, Myoung-don, Huprikar, Nikhil, Hohmann, Elizabeth, Kelley, Colleen F, Holodniy, Mark, Kim, Eu Suk, Sweeney, Daniel A, Finberg, Robert W, Grimes, Kevin A, Maves, Ryan C, Ko, Emily R, Engemann, John J, Taylor, Barbara S, Ponce, Philip O, Larson, LuAnn, Melendez, Dante Paolo, Seibert, Allan M, Rouphael, Nadine G, Strebe, Joslyn, Clark, Jesse L, Julian, Kathleen G, de Leon, Alfredo Ponce, Cardoso, Anabela, de Bono, Stephanie, Atmar, Robert L, Ganesan, Anuradha, Ferreira, Jennifer L, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, and Kalil, Andre C

Published
2022
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15. Clinicomicrobiological risk factors for infective endocarditis in viridans group streptococci bacteraemia.

Author

Bae, Jiyeon, Park, Jae Hyeon, Lee, Minkyeong, Jo, Hyeon Jae, Lee, Chan Mi, Kang, Chang Kyung, Choe, Pyoeng Gyun, Park, Wan Beom, Kim, Nam Joong, Kim, Inho, and Oh, Myoung-don

Subjects
HEART valve diseases, HEMATOLOGIC malignancies, DISEASE risk factors, BLOOD diseases, LOGISTIC regression analysis
Abstract

Background When to perform echocardiography to rule out infective endocarditis (IE) in patients with viridans group streptococci (VGS) bloodstream infections (BSIs) is unclear. Objectives We aimed to identify independent risk factors for IE in patients with VGS BSI. Methods This retrospective study conducted at Seoul National University Hospital from January 2013 to December 2022 involved patients with VGS and nutritionally variant streptococcal BSI, excluding single positive blood cultures and polymicrobial BSI cases. Independent risk factors were identified by multivariate logistic regression and sensitivity analyses according to echocardiography results, VGS species or the inclusion of possible IE cases. Results Of 845 VGS BSI cases, 349 were analysed and 86 IE cases were identified (24.6%). In the multivariate analysis, heart valve disease [adjusted odds ratio (aOR), 14.14, 95% CI, 6.14–32.58; P  < 0.001], persistent bacteraemia (aOR, 5.12, 95% CI, 2.03–12.94; P  = 0.001), age (per year, aOR, 0.98; 95% CI, 0.96–1.00; P =  0.015), solid cancer (aOR, 0.26; 95% CI, 0.13–0.53; P <  0.001) and haematologic malignancy (aOR, 0.04; 95% CI, 0.01–0.41; P =  0.006) were independently associated with IE. Sensitivity analyses yielded consistent results; also, infection by a member of the mitis group was independent risk factor for IE (aOR, 6.50; 95% CI, 2.87–14.68; P  < 0.001). Conclusions Younger age, heart valve disease, persistent bacteraemia, absence of underlying malignancy and BSI by a member of the mitis group were independent risk factors for IE in patients with VGS BSI. Echocardiographic evaluation could be prudently considered based on these clinicomicrobiological risk factors. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Comparison of Complications after Coronavirus Disease and Seasonal Influenza, South Korea

Author

Lee, Hyejin, Sung, Ho Kyung, Lee, Dokyoung, Choi, Yeonmi, Lee, Ji Yoon, Lee, Jin Yong, and Oh, Myoung-don

Subjects
Influenza -- Statistics -- Complications and side effects -- Comparative analysis, Health
Abstract

The symptoms, incidence, and risk for complications of coronavirus disease (COVID-19) remain controversial. Several types of long COVID, meaning prolonged symptoms or long-term complications of COVID-19, have been reported (1). [...]

Published
2022
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17. Surface-Aerosol Stability and Pathogenicity of Diverse Middle East Respiratory Syndrome Coronavirus Strains, 2012-2018

Author

van Doremalen, Neeltje, Letko, Michael, Fischer, Robert J., Bushmaker, Trenton, Schulz, Jonathan, Yinda, Claude K., Seifert, Stephanie N., Kim, Nam Joong, Hemida, Maged G., Kayali, Ghazi, Park, Wan Beom, Perera, Ranawaka A.P.M., Tamin, Azaibi, Thornburg, Natalie J., Tong, Suxiang, Queen, Krista, van Kerkhove, Maria D., Choi, Young Ki, Oh, Myoung-don, Assiri, Abdullah M., Peiris, Malik, Gerber, Susan I., and Munster, Vincent J.

Subjects
Bioaerosols -- Health aspects -- Environmental aspects -- Chemical properties, Coronaviruses -- Physiological aspects -- Environmental aspects, Health
Abstract

Middle East respiratory syndrome coronavirus (MERS-CoV) was detected during 2012 and continues to cause outbreaks as a result of frequent spillover from dromedary camels to humans. Human infection with MERS-CoV [...]

Published
2021
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18. Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Hewlett, Angela, Taylor, Barbara S, Bowling, Jason E, Serrano, Ruth C, Rouphael, Nadine G, Wiley, Zanthia, Phadke, Varun K, Certain, Laura, Imlay, Hannah N, Engemann, John J, Walter, Emmanuel B, Meisner, Jessica, Rajme, Sandra, Billings, Joanne, Kim, Hyun, Martinez-Orozco, Jose A, Bautista Felix, Nora, Elmor, Sammy T, Bristow, Laurel R, Mertz, Gregory, Sosa, Nestor, Bell, Taison D, West, Miranda J, Elie-Turenne, Marie-Carmelle, Grein, Jonathan, Sutterwala, Fayyaz, Gyun Choe, Pyoeng, Kyung Kang, Chang, El Sahly, Hana M, Rhie, Kevin S, Hussein, Rezhan H, Winokur, Patricia L, Mikami, Ayako, Saito, Sho, Benson, Constance A, McConnell, Kimberly, Berhe, Mezgebe, Dishner, Emma, Frank, Maria G, Sarcone, Ellen, Crouch, Pierre-Cedric B, Jang, Hannah, Jilg, Nikolaus, Perez, Katherine, Janak, Charles, Cantos, Valeria D, Rebolledo, Paulina A, Gharbin, John, Zingman, Barry S, Riska, Paul F, Falsey, Ann R, Walsh, Edward E, Branche, Angela R, Arguinchona, Henry, Arguinchona, Christa, Van Winkle, Jason W, Zea, Diego F, Jung, Jongtak, Song, Kyoung-Ho, Kim, Hong Bin, Dwyer, Jay, Bainbridge, Emma, Hostler, David C, Hostler, Jordanna M, Shahan, Brian T, Hsieh, Lanny, Amin, Alpesh N, Watanabe, Miki, Short, William R, Tebas, Pablo, Baron, Jillian T, Ahuja, Neera, Ling, Evelyn, Go, Minjoung, Yang, Otto O, Ahn, Jenny, Arias, Rubi, Rapaka, Rekha R, Hubbard, Fleesie A, Campbell, James D, Cohen, Stuart H, Thompson, George R, 3rd, Chakrabarty, Melony, Taylor, Stephanie N, Masri, Najy, Lacour, Alisha, Lee, Tida, Lalani, Tahaniyat, Lindholm, David A, Markelz, Ana Elizabeth, Mende, Katrin, Colombo, Christopher J, Schofield, Christina, Colombo, Rhonda E, Guirgis, Faheem, Holodniy, Mark, Chary, Aarthi, Bessesen, Mary, Hynes, Noreen A, Sauer, Lauren M, Marconi, Vincent C, Moanna, Abeer, Harrison, Telisha, Lye, David C, Ong, Sean W X, Ying Chia, Po, Huprikar, Nikhil, Ganesan, Anuradha, Madar, Christian, Novak, Richard M, Wendrow, Andrea, Borgetti, Scott A, George, Sarah L, Hoft, Daniel F, Brien, James D, McLellan, Susan L F, Levine, Corri, Nock, Joy, Yen Tan, Seow, Shafi, Humaira, Chien, Jaime M F, Candiotti, Keith, Finberg, Robert W, Wang, Jennifer P, Wessolossky, Mireya, Utz, Gregory C, Chambers, Susan E, Stephens, David S, Burgess, Timothy H, Rozman, Julia, Hyvert, Yann, Seitzinger, Andrea, Osinusi, Anu, Cao, Huyen, Chung, Kevin K, Conrad, Tom M, Cross, Kaitlyn, El-Khorazaty, Jill A, Hill, Heather, Pettibone, Stephanie, Wierzbicki, Michael R, Gettinger, Nikki, Engel, Theresa, Lewis, Teri, Wang, Jing, Deye, Gregory A, Nomicos, Effie, Pikaart-Tautges, Rhonda, Elsafy, Mohamed, Jurao, Robert, Koo, Hyung, Proschan, Michael, Davey, Richard, Yokum, Tammy, Arega, Janice, Florese, Ruth, Kalil, Andre C, Mehta, Aneesh K, Patterson, Thomas F, Erdmann, Nathaniel, Gomez, Carlos A, Jain, Mamta K, Wolfe, Cameron R, Ruiz-Palacios, Guillermo M, Kline, Susan, Regalado Pineda, Justino, Luetkemeyer, Anne F, Harkins, Michelle S, Jackson, Patrick E H, Iovine, Nicole M, Tapson, Victor F, Oh, Myoung-don, Whitaker, Jennifer A, Mularski, Richard A, Paules, Catharine I, Ince, Dilek, Takasaki, Jin, Sweeney, Daniel A, Sandkovsky, Uriel, Wyles, David L, Hohmann, Elizabeth, Grimes, Kevin A, Grossberg, Robert, Laguio-Vila, Maryrose, Lambert, Allison A, Lopez de Castilla, Diego, Kim, EuSuk, Larson, LuAnn, Wan, Claire R, Traenkner, Jessica J, Ponce, Philip O, Patterson, Jan E, Goepfert, Paul A, Sofarelli, Theresa A, Mocherla, Satish, Ko, Emily R, Ponce de Leon, Alfredo, Doernberg, Sarah B, Atmar, Robert L, Maves, Ryan C, Dangond, Fernando, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori, Tomashek, Kay M, and Beigel, John H

Published
2021
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20. Risk factors for early mortality in Acinetobacter baumannii bacteremia and the effect of the bacterial virulence

Author

Ham, Sin Young, primary, Chun, June Young, additional, Song, Kyoung-Ho, additional, Kang, Chang Kyung, additional, Park, Jeong Su, additional, Jo, Hee Bum, additional, Ryu, Choong-Min, additional, Choi, Yunsang, additional, Choi, Seong Jin, additional, Lee, Eunyoung, additional, Choe, Pyoeng Gyun, additional, Moon, Song Mi, additional, Park, Wan Beom, additional, Bang, Jihwan, additional, Park, Sang-Won, additional, Park, Kyoung Un, additional, Kim, Nam Joong, additional, Oh, Myoung-don, additional, Kim, Eu Suk, additional, and Kim, Hong Bin, additional

Published
2024
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22. Antibody Responses 8 Months after Asymptomatic or Mild SARS-CoV-2 Infection

Author

Choe, Pyoeng Gyun, Kim, Kye-Hyung, Kang, Chang Kyung, Suh, Hyeon Jeong, Kang, EunKyo, Lee, Sun Young, Kim, Nam Joong, Yi, Jongyoun, Park, Wan Beom, and Oh, Myoung-don

Subjects
Immune response -- Health aspects, Viral antibodies -- Physiological aspects -- Health aspects, Antibodies -- Physiological aspects -- Health aspects, Health
Abstract

Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) leads to an antibody response, even in those who are completely asymptomatic. However, the initial immune response is not as strong [...]

Published
2021
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25. A minimal common outcome measure set for COVID-19 clinical research

Author

Marshall, John C, Murthy, Srinivas, Diaz, Janet, Adhikari, N K, Angus, Derek C, Arabi, Yaseen M, Baillie, Kenneth, Bauer, Michael, Berry, Scott, Blackwood, Bronagh, Bonten, Marc, Bozza, Fernando, Brunkhorst, Frank, Cheng, Allen, Clarke, Mike, Dat, Vu Quoc, de Jong, Menno, Denholm, Justin, Derde, Lennie, Dunning, Jake, Feng, Xiaobin, Fletcher, Tom, Foster, Nadine, Fowler, Rob, Gobat, Nina, Gomersall, Charles, Gordon, Anthony, Glueck, Thomas, Harhay, Michael, Hodgson, Carol, Horby, Peter, Kim, YaeJean, Kojan, Richard, Kumar, Bharath, Laffey, John, Malvey, Denis, Martin-Loeches, Ignacio, McArthur, Colin, McAuley, Danny, McBride, Stephen, McGuinness, Shay, Merson, Laura, Morpeth, Susan, Needham, Dale, Netea, Mihai, Oh, Myoung-Don, Phyu, Sabai, Piva, Simone, Qiu, Ruijin, Salisu-Kabara, Halima, Shi, Lei, Shimizu, Naoki, Sinclair, Jorge, Tong, Steven, Turgeon, Alexis, Uyeki, Tim, van de Veerdonk, Frank, Webb, Steve, Williamson, Paula, Wolf, Timo, and Zhang, Junhua

Published
2020
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27. A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein

Author

Kim, Cheolmin, Ryu, Dong-Kyun, Lee, Jihun, Kim, Young-Il, Seo, Ji-Min, Kim, Yeon-Gil, Jeong, Jae-Hee, Kim, Minsoo, Kim, Jong-In, Kim, Pankyeom, Bae, Jin Soo, Shim, Eun Yeong, Lee, Min Seob, Kim, Man Su, Noh, Hanmi, Park, Geun-Soo, Park, Jae Sang, Son, Dain, An, Yongjin, Lee, Jeong No, Kwon, Ki-Sung, Lee, Joo-Yeon, Lee, Hansaem, Yang, Jeong-Sun, Kim, Kyung-Chang, Kim, Sung Soon, Woo, Hye-Min, Kim, Jun-Won, Park, Man-Seong, Yu, Kwang-Min, Kim, Se-Mi, Kim, Eun-Ha, Park, Su-Jin, Jeong, Seong Tae, Yu, Chi Ho, Song, Youngjo, Gu, Se Hun, Oh, Hanseul, Koo, Bon-Sang, Hong, Jung Joo, Ryu, Choong-Min, Park, Wan Beom, Oh, Myoung-don, Choi, Young Ki, and Lee, Soo-Young

Published
2021
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28. Clonal hematopoiesis is associated with risk of severe Covid-19

Author

Bolton, Kelly L., Koh, Youngil, Foote, Michael B., Im, Hogune, Jee, Justin, Sun, Choong Hyun, Safonov, Anton, Ptashkin, Ryan, Moon, Joon Ho, Lee, Ji Yeon, Jung, Jongtak, Kang, Chang Kyung, Song, Kyoung-Ho, Choe, Pyoeng Gyun, Park, Wan Beom, Kim, Hong Bin, Oh, Myoung-don, Song, Han, Kim, Sugyeong, Patel, Minal, Derkach, Andriy, Gedvilaite, Erika, Tkachuk, Kaitlyn A., Wiley, Brian J., Chan, Ireaneus C., Braunstein, Lior Z., Gao, Teng, Papaemmanuil, Elli, Esther Babady, N., Pessin, Melissa S., Kamboj, Mini, Diaz, Jr, Luis A., Ladanyi, Marc, Rauh, Michael J., Natarajan, Pradeep, Machiela, Mitchell J., Awadalla, Philip, Joseph, Vijai, Offit, Kenneth, Norton, Larry, Berger, Michael F., Levine, Ross L., Kim, Eu Suk, Kim, Nam Joong, and Zehir, Ahmet

Published
2021
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31. Antibody Responses to SARS-CoV-2 at 8 Weeks Postinfection in Asymptomatic Patients

Author

Choe, Pyoeng Gyun, Kang, Chang Kyung, Suh, Hyeon Jeong, Jung, Jongtak, Kang, EunKyo, Lee, Sun Young, Song, Kyoung-Ho, Kim, Hong Bin, Kim, Nam Joong, Park, Wan Beom, Kim, Eu Suk, and Oh, Myoung-Don

Subjects
Severe acute respiratory syndrome -- Development and progression, Coronaviruses -- Health aspects, Antibodies -- Health aspects, COVID-19 -- Development and progression, Health
Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a new strain of betacoronavirus that causes coronavirus disease (COVID-19), quickly spread worldwide; the World Health Organization declared COVID-19 a pandemic on March [...]

Published
2020
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32. Serologic Detection of Middle East Respiratory Syndrome Coronavirus Functional Antibodies

Author

Okba, Nisreen M.A., Widjaja, Ivy, Li, Wentao, GeurtsvanKessel, Corine H., Farag, Elmoubasher A.B.A., Hajri, Mohammed Al-, Park, Wan Beom, Oh, Myoung-Don, Reusken, Chantal B.E.M., Koopmans, Marion P.G., Bosch, Berend-Jan, and Haagmans, Bart L.

Subjects
Vaccines, Recombinant proteins, Coronaviruses, Middle East respiratory syndrome, Antibodies, Biosafety, Organic acids, Biopharmaceuticals, Health
Abstract

The zoonotic introductions and ongoing outbreaks of Middle East respiratory syndrome (MERS) coronavirus (MERS-CoV) pose a global threat (1,2) necessitating continuous serosurveillance to monitor virus spread alongside the development of [...]

Published
2020
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33. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial

Author

Modjarrad, Kayvon, Roberts, Christine C, Mills, Kristin T, Castellano, Amy R, Paolino, Kristopher, Muthumani, Kar, Reuschel, Emma L, Robb, Merlin L, Racine, Trina, Oh, Myoung-don, Lamarre, Claude, Zaidi, Faraz I, Boyer, Jean, Kudchodkar, Sagar B, Jeong, Moonsup, Darden, Janice M, Park, Young K, Scott, Paul T, Remigio, Celine, Parikh, Ajay P, Wise, Megan C, Patel, Ami, Duperret, Elizabeth K, Kim, Kevin Y, Choi, Hyeree, White, Scott, Bagarazzi, Mark, May, Jeanine M, Kane, Deborah, Lee, Hyojin, Kobinger, Gary, Michael, Nelson L, Weiner, David B, Thomas, Stephen J, and Maslow, Joel N

Published
2019
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34. An ancestral SARS-CoV-2 vaccine induces anti-Omicron variants antibodies by hypermutation.

Author

Park, Seoryeong, Choi, Jaewon, Lee, Yonghee, Noh, Jinsung, Kim, Namphil, Lee, JinAh, Cho, Geummi, Kim, Sujeong, Yoo, Duck Kyun, Kang, Chang Kyung, Choe, Pyoeng Gyun, Kim, Nam Joong, Park, Wan Beom, Kim, Seungtaek, Oh, Myoung-don, Kwon, Sunghoon, and Chung, Junho

Subjects
COVID-19 vaccines, SARS-CoV-2 Omicron variant, SARS-CoV-2, B cells, IMMUNOGLOBULINS, ANTIBODY formation, B cell receptors
Abstract

The immune escape of Omicron variants significantly subsides by the third dose of an mRNA vaccine. However, it is unclear how Omicron variant-neutralizing antibodies develop under repeated vaccination. We analyze blood samples from 41 BNT162b2 vaccinees following the course of three injections and analyze their B-cell receptor (BCR) repertoires at six time points in total. The concomitant reactivity to both ancestral and Omicron receptor-binding domain (RBD) is achieved by a limited number of BCR clonotypes depending on the accumulation of somatic hypermutation (SHM) after the third dose. Our findings suggest that SHM accumulation in the BCR space to broaden its specificity for unseen antigens is a counterprotective mechanism against virus variant immune escape. Repeat vaccination with COVID-19 mRNA vaccines has been shown to increase breadth of the antibody response. Here the authors demonstrate that B cell clones induced by the ancestral COVID-19 vaccine develop into daughter clones with different reactivity to individual SARS-CoV-2 variants through the accumulation of somatic hypermutations. [ABSTRACT FROM AUTHOR]

Published
2024
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36. 259. Long-term Transcriptomic Changes in the CD4 T cells Following Treatment of Extrapulmonary Tuberculosis

Author

Jin Choi, Seong, primary, Kim, Young-Jun, additional, Seok Lee, Jeong, additional, Choi, Yunsang, additional, Mi Moon, Song, additional, Kim, Nak-Hyun, additional, Song, Kyong-Ho, additional, Suk Kim, Eu, additional, Kyung Kang, Chang, additional, Gyun Choe, Pyoeng, additional, Beom Park, Wan, additional, Joong Kim, Nam, additional, Oh, Myoung-don, additional, Shin, Eui-Cheol, additional, and Bin Kim, Hong, additional

Published
2023
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37. Empirical vs pre-emptive broad-spectrum antifungal therapy for acute myelogenous leukaemia in the era of antimould prophylaxis

Author

Oh, Sang-Min, primary, Byun, Ja Min, additional, Lee, Chan Mi, additional, Kang, Chang Kyung, additional, Shin, Dong-Yeop, additional, Koh, Youngil, additional, Hong, Junshik, additional, Choe, Pyoeng Gyun, additional, Park, Wan Beom, additional, Kim, Nam Joong, additional, Yoon, Sung-Soo, additional, Kim, Inho, additional, and Oh, Myoung-don, additional

Published
2023
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39. Sensitive and Specific Detection of Low-Level Antibody Responses in Mild Middle East Respiratory Syndrome Coronavirus Infections

Author

Okba, Nisreen M.A., Raj, V. Stalin, Widjaja, Ivy, GeurtsvanKessel, Corine H., Bruin, Erwin de, Chandler, Felicity D., Park, Wan Beom, Kim, Nam-Joong, Farag, Elmoubasher A.B.A., Hajri, Mohammed Al-, Bosch, Berend-Jan, Oh, Myoung-don, Koopmans, Marion P.G., Reusken, Chantal B.E.M., and Haagmans, Bart L.

Subjects
Enzyme-linked immunosorbent assay -- Health aspects, Diseases -- Research -- Health aspects -- Netherlands -- Middle East -- South Korea -- Qatar, Middle East respiratory syndrome -- Research -- Health aspects, Antibodies -- Health aspects, Disease transmission, Coronavirus infections, Intelligence gathering, Lung diseases, Infection, Respiratory tract diseases, Health
Abstract

Middle East respiratory syndrome coronavirus (MERS-CoV) poses a public health threat; ongoing outbreaks have been reported since its detection in 2012 (1). MERS-CoV infection may be asymptomatic or may cause [...]

Published
2019
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40. Waning Antibody Responses in Asymptomatic and Symptomatic SARS-CoV-2 Infection

Author

Choe, Pyoeng Gyun, Kang, Chang Kyung, Suh, Hyeon Jeong, Jung, Jongtak, Song, Kyoung-Ho, Bang, Ji Hwan, Kim, Eu Suk, Kim, Hong Bin, Park, Sang Won, Kim, Nam Joong, Park, Wan Beom, and Oh, Myoung-don

Subjects
Epidemics -- Physiological aspects -- South Korea, Immune response -- Observations, Viral antibodies -- Identification and classification, Antibodies -- Identification and classification, Health
Abstract

Neutralizing antibodies develop in asymptomatic persons with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; however, the initial immune response is not as strong as in patients with more severe [...]

Published
2021
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43. Intervention for the Reduction of Long-term Carbapenem Prescriptions

Author

Choi, Seong Jin, primary, Lee, Dong Eun, additional, Song, Su Jeong, additional, Kang, Hyein, additional, Lee, Chan Mi, additional, Kang, Chang Kyung, additional, Park, Wan Bum, additional, Kim, Nam Joong, additional, Choi, Eun Hwa, additional, Oh, Myoung-don, additional, and Choe, Pyoeng Gyun, additional

Published
2023
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49. Clinical outcomes and immunological features of COVID-19 patients receiving B-cell depletion therapy during the Omicron era.

Author

Lee, Chan Mi, Kim, Minji, Park, Seong-wook, Kang, Chang Kyung, Choe, Pyoeng Gyun, Kim, Nam Joong, Jo, Hyeon Jae, Shin, Hyun Mu, Lee, Chang-Han, Kim, Hang-Rae, Park, Wan Beom, and Oh, Myoung-don

Subjects
COVID-19, SARS-CoV-2 Omicron variant, COVID-19 pandemic, HUMORAL immunity, TREATMENT effectiveness
Abstract

Background: The clinical outcomes and immunological features of coronavirus disease 2019 (COVID-19) patients receiving B-cell depletion therapy (BCDT), especially in Omicron variant era, have not been fully elucidated. We aimed to investigate the outcomes and immune responses of COVID-19 patients receiving BCDT during the Omicron period. Methods: We retrospectively compared clinical outcomes between COVID-19 patients treated with BCDT (the BCDT group) and those with the same underlying diseases not treated with BCDT (the non-BCDT group). For immunological analyses, we prospectively enrolled COVID-19 patients receiving BCDT and immunocompetent COVID-19 patients as controls. We measured humoral and cellular immune responses using the enzyme-linked immunosorbent assay and flow cytometry. Results: Severe to critical COVID-19 was more frequent in the BCDT group than in the non-BCDT group (41.9% vs. 28.3%, p =.030). BCDT was an independent risk factor for severe to critical COVID-19 (adjusted odds ratio [aOR] 2.21, 95% confidence interval [CI] 1.21–4.04, p =.010) as well as for COVID-19-related mortality (aOR 4.03, 95% CI 1.17–13.86, p =.027). Immunological analyses revealed that patients receiving BCDT had lower anti-S1 IgG titres and a tendency to higher proportions of activated CD4+ T-cells than the controls. Conclusions: BCDT was associated with worse COVID-19 outcomes in the Omicron period. Humoral immune response impairment and T-cell hyperactivation were the main immunological features of COVID-19 patients treated with BCDT, which may have contributed to the worse outcomes of COVID-19 in this population. [ABSTRACT FROM AUTHOR]

Published
2024
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50. Risk factors for resistant Gram-positive bacteremia in febrile neutropenic patients with cancer

Author

Lee, Minkyeong, primary, Lee, Chan Mi, additional, Byun, Ja min, additional, Shin, Dong-Yeop, additional, Koh, Youngil, additional, Hong, Junshik, additional, Choe, Pyoeng Gyun, additional, Park, Wan Beom, additional, Kim, Nam Joong, additional, Yoon, Sung-Soo, additional, Oh, Myoung-don, additional, Kang, Chang Kyung, additional, and Kim, Inho, additional

Published
2023
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