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1. Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients

Author

Rokx, Casper, Lammers, Jolanda, Buitenhuis, Lonneke, Postma, Douwe, Koster, David, Lukens, Michaèl, Scholtens, Thea, Boomgaard, Maartje van den, Kampschreur, Linda, Ubals, Maria, Prat, Núria, Díez Sánchez, Beatriz, Vértiz Guidotti, Thatiana, Pons Barber, Maria, Gonzalez Ruiz, Cristian, Navarrete Gonzalez, Laura, Ancochea, Àgueda, Ferrer, Magí, Videla, Sebas, Gudiol, Carlota, Fernández Rivas, Gema, CoV-Early Study Group, Vonderen, Marit van, Bianco, Andrea Sofia, Bravo, Anna, Otero, Aurema, Ruibal Suarez, Jose Carlos, Benavent, Sergio, Zarauza Pellejero, Alvaro, Línio, Rosa, Malchair, Pierre, Llopis Roca, Ferran, Blanco, Julian, Rodriguez Cortez, Orlando, Casares Gonzalez, Pablo, Arcos Vila, Gemma, García, Yolanda, Roca Font, Judit, Carrasco Matos, Katherine M., Saüch Valmaña, Glòria, Vidal Obradors, Carla, Koopmans, Marion, Ara, Jordi, COnV-ert Study Group, Rodríguez Codina, Joana, Tarres García, Silvia, Blanco, Ignacio, Hernández, Águeda, González Soler, Victoria, Curriu Sabatès, Margarida, Nieto Rodríguez, Raquel, Grífols, Joan Ramon, Briones Zambrano, Ney Nicanor, Millan, Anna, Capdevila Jáuregui, Mar, Fornos, Miriam, Casamitjana, Natàlia, Bordoy, Antoni E., Alonso, Eva, Zwet, Erik van, Miedema, Jelle, Martinez, Núria, Ramírez Morros, Anna, Bogers, Susanne, Maglio, Laura Analía, Amado Simon, Rosa, Comellas Fernandez, Laura, Garcia, Nadia, Ruiz Comellas, Anna, Baro, Bàrbara, Hernández, Luis, Viozquez Meya, Maria, Costes, Gèlia, Pradenas, Edwars, Forcada, Anna, Ginneken, Betty van, Harvala, Heli, Marfil, Silvia, Troxel, Andrea, Mooijaart, Simon, Trinité, Benjamin, Piccolo Ferreira, Francini, Bonet, Mireia, Cantoni, Jordi, Russcher, Henk, Marks, Michael, Zwaginga, Jaap Jan, Torrano Soler, Pamela, Mitjà, Oriol, Rijnders, Bart J. A., Droog, José de, Corbacho Monné, Marc, Scherpenisse, Cees, Hollander, Jan den, Gharbharan, Arvind, Jordans, Carlijn, Geurtsvankessel, Corine, Albersen, Arjan, Papageourgiou, Grigorios, Katsikis, Peter, Vall Mayans, Martí, Müller, Yvonne, Reusken, Chantal, San José, Alba, Ferrer, Susana, Engen, Rene van, Karisli, Ayten, Götz, Hannelore, Struik, Jelle, París, Alexa, Suñer Navarro, Clara, Clotet, Bonaventura, 1953, Reimerink, Johan, Rokx-Niemantsverdriet, Lotte, Rodriguez Arias, Miquel Angel, Jiménez, Zahida, Verstijnen, Jose, Geloven, Nan van, Groeneveld, Geert, Zwaginga, Lisa, Oud, Josine, Meier, Romy, González Beiras, Camila, Swaneveld, Francis, Ramírez Viaplana, Ferran, Schoot, Ellen van der, Vrielink, Hans, Flores Aguilera, Begoña, Vivero Larraza, Ainhoa, Watering, Leo van de, Hogema, Boris, González García, David, Wijngaarden, Peter van, Vidal Alaball, Josep, Etten, Ronald van, Gammeren, Adriaan van, Alemany, Andrea, Puig, Jordi, Maas, Nanda, Berg – Rahman, Juliette van der, Karim, Faiz, Hiddema, Siepke, Elst, Kim van, García García, Vanesa, Casañ Lopez, Cristina, Leeuwen-Segarceanu, Elena van, Nieto, Aroa, Rodríguez Sevilla, Graciela, Reitsma, Annette, Molenkamp, Karin, Soetekouw, Robert, Band, Caterina, Carceles Peiró, Victor, Gallardo, Mireia, Galvan Femenia, Ivan, Comas Leon, Xavier, Millat Martínez, Pere, Bassat Orellana, Quique, González, María Isabel, Verdaguer, Joaquim, Roquer López, Clàudia, Contreras, Enric, Giménez, Montserrat, Ouchi, Dan, Blanco Guillermo, Ignacio, Bonet Papell, Glòria, Dastis Arias, Macarena, Delgado Capel, Maria, Faculteit Medische Wetenschappen/UMCG, Internal Medicine, Medical Microbiology & Infectious Diseases, Virology, and Epidemiology

Subjects
Immunoregulació, Multidisciplinary, SARS-CoV-2, Immunization, Passive, Immunoregulation, COVID-19, General Physics and Astronomy, Bayes Theorem, General Chemistry, Middle Aged, General Biochemistry, Genetics and Molecular Biology, Treatment Outcome, Outpatients, Humans, Multicenter Studies as Topic, COVID-19 Serotherapy, Randomized Controlled Trials as Topic
Abstract

Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when Trial registration: Clinicaltrials.gov NCT04621123 and NCT04589949. Registration: NCT04621123 and NCT04589949 on https://www.clinicaltrials.gov

Published
2022

2. Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients

Author

Millat-Martinez, Pere, Gharbharan, Arvind, Alemany, Andrea, Rokx, Casper, Geurtsvankessel, Corine, Papageourgiou, Grigorios, van Geloven, Nan, Jordans, Carlijn, Groeneveld, Geert, Swaneveld, Francis, van der Schoot, Ellen, Corbacho-Monné, Marc, Ouchi, Dan, Piccolo Ferreira, Francini, Malchair, Pierre, Videla, Sebastian, García García, Vanesa, Ruiz-Comellas, Anna, Ramírez-Morros, Anna, Rodriguez Codina, Joana, Amado Simon, Rosa, Grifols, Joan-Ramon, Blanco, Julian, Blanco, Ignacio, Ara, Jordi, Bassat, Quique, Clotet, Bonaventura, Baro, Bàrbara, Troxel, Andrea, Zwaginga, Jaap Jan, Mitjà, Oriol, Rijnders, Bart J A, Millat-Martinez, Pere, Gharbharan, Arvind, Alemany, Andrea, Rokx, Casper, Geurtsvankessel, Corine, Papageourgiou, Grigorios, van Geloven, Nan, Jordans, Carlijn, Groeneveld, Geert, Swaneveld, Francis, van der Schoot, Ellen, Corbacho-Monné, Marc, Ouchi, Dan, Piccolo Ferreira, Francini, Malchair, Pierre, Videla, Sebastian, García García, Vanesa, Ruiz-Comellas, Anna, Ramírez-Morros, Anna, Rodriguez Codina, Joana, Amado Simon, Rosa, Grifols, Joan-Ramon, Blanco, Julian, Blanco, Ignacio, Ara, Jordi, Bassat, Quique, Clotet, Bonaventura, Baro, Bàrbara, Troxel, Andrea, Zwaginga, Jaap Jan, Mitjà, Oriol, and Rijnders, Bart J A

Abstract

Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when <20% of recruitment target was achieved. A Bayesian-adaptive individual patient data meta-analysis was implemented. Outpatients aged ≥50 years and symptomatic for ≤7days were included. The intervention consisted of 200–300mL of CP with a predefined minimum level of antibodies. Primary endpoints were a 5-point disease severity scale and a composite of hospitalization or death by 28 days. Amongst the 797 patients included, 390 received CP and 392 placebo; they had a median age of 58 years, 1 comorbidity, 5 days symptoms and 93% had negative IgG antibody-test. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The odds ratio (OR) of CP for improved disease severity scale was 0.936 (credible interval (CI) 0.667–1.311); OR for hospitalization or death was 0.919 (CI 0.592–1.416). CP effect on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95%CI 0.394–1.085). CP did not decrease the time to full symptom resolution. Trial registration: Clinicaltrials.gov NCT04621123 and NCT04589949. Registration: NCT04621123 and NCT04589949 on https://www.clinicaltrials.gov

Published
2022

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