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

Millat-Martinez, P; Gharbharan, A; Alemany, A; Rokx, CORCID logo; Geurtsvankessel, CORCID logo; Papageorgiou, G; van Geloven, NORCID logo; Jordans, C; Groeneveld, G; Swaneveld, F; +24 more...van der Schoot, E; Corbacho-Monné, M; Ouchi, DORCID logo; Piccolo Ferreira, FORCID logo; Malchair, P; Videla, SORCID logo; García García, V; Ruiz-Comellas, AORCID logo; Ramírez-Morros, AORCID logo; Rodriguez Codina, J; Amado Simon, R; Grifols, J; Blanco, JORCID logo; Blanco, IORCID logo; Ara, J; Bassat, QORCID logo; Clotet, B; Baro, BORCID logo; Troxel, A; Zwaginga, JJ; Mitjà, O; Rijnders, BJORCID logo; CoV-Early study group; COnV-ert study group and (2022) Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients. Nature Communications, 13 (1). 2583-. ISSN 2041-1723 DOI: 10.1038/s41467-022-29911-3
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UNLABELLED: 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.


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