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

2022; Nature Portfolio; Volume: 13; Issue: 1 Linguagem: Inglês

10.1038/s41467-022-29911-3

2041-1723

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

SARS-CoV-2 and COVID-19 Research

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