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

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

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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: NCT04621123 and NCT04589949. Registration: NCT04621123 and NCT04589949 on

Original languageEnglish
Article number2583
JournalNature Communications
Issue number1
Publication statusPublished - Dec-2022

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