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.

© 2022. The Author(s).

Overview publication

TitleProspective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients.
DateMay 11th, 2022
Issue nameNature communications
Issue numberv13.1:2583
DOI10.1038/s41467-022-29911-3
AuthorsMillat-Martinez P, Gharbharan A, Alemany A, Rokx C, Geurtsvankessel C, Papageorgiou G, van Geloven N, Jordans C, Groeneveld G, Swaneveld F, van der Schoot E, Corbacho-Monné M, Ouchi D, Piccolo Ferreira F, Malchair P, Videla S, García García V, Ruiz-Comellas A, Ramírez-Morros A, Rodriguez Codina J, Amado Simon R, Grifols JR, Blanco J, Blanco I, Ara J, Bassat Q, Clotet B, Baro B, Troxel A, Zwaginga JJ, Mitjà O & Rijnders BJA
InfoGharbharan A, Rokx C, Jordans C, Geurtsvankessel C, Papageorgiou G, Rijnders B, Katsikis P, Müller Y, Koopmans M, Bogers S, Miedema J, Russcher H, Scherpenisse C, van Engen R, Karisli A, Götz H, Struik J, Rokx-Niemantsverdriet L, van Geloven N, Groeneveld G, Jan Zwaginga J, Zwaginga L, Oud J, Meier R, van Zwet E, Mooijaart S, Albersen A, Swaneveld F, van der Schoot E, Vrielink H, van de Watering L, Hogema B, van Wijngaarden P, van Etten R, van Gammeren A, Maas N, van Ginneken B, den Hollander J, Verstijnen J, van den Berg-Rahman J, Karim F, Hiddema S, van Elst K, van Leeuwen-Segarceanu E, Reitsma A, Molenkamp K, Soetekouw R, Band C, de Droog J, Lammers J, Buitenhuis L, Postma D, Koster D, Lukens M, Scholtens T, van den Boomgaard M, Vonk M, Kampschreur L, van Vonderen M, Vrolijk L, Reusken C, Reimerink J, Harvala H, Alemany A, Corbacho-Monné M, Ouchi D, Clotet B, Mitjà O, Costes G, Capdevila-Jáuregui M, Torrano-Soler P, San José A, Jiménez Z, Ramírez-Viaplana F, Ferrer S, Gallardo M, Ubals M, González-Beiras C, Vall-Mayans M, Rodriguez-Arias MA, Suñer C, Puig J, Nieto A, Galvan-Femenia I, Comas-Leon X, Millat-Martínez P, Bassat Q, Baro B, Blanco I, Ara J, Bonet Papell G, Delgado Capel M, Díez Sánchez B, Pons Barber M, Gonzalez Ruiz C, Navarrete Gonzalez L, González García D, Vivero Larraza A, Carceles Peiró V, Roquer López C, Ferrer M, Malchair P, Videla S, García García V, Gudiol C, Otero A, Ruibal Suarez JC, Pellejero AZ, Llopis Roca F, Rodriguez Cortez O, Casares Gonzalez P, Arcos Vila G, Flores Aguilera B, Rodríguez-Sevilla G, Dastis Arias M, Ruiz-Comellas A, Ramírez-Morros A, Roca Font J, Carrasco Matos KM, Saüch Valmaña G, Vidal Obradors C, Rodríguez Codina J, Amado Simon R, Tarres García S, Curriu Sabatès M, Nieto Rodríguez R, Grífols JR, Millan A, Contreras E, Ancochea À, Línio R, Fornos M, Casamitjana N, Alonso E, Martinez N, Maglio LA, Comellas Fernandez L, Garcia N, Hernández L, González MI, Bravo A, García Y, Prat N, Verdaguer J, Vértiz Guidotti T, Benavent S, Bianco AS, Briones Zambrano NN, Viozquez Meya M, Forcada A, Vidal-Alaball J, Giménez M, París A, Fernández Rivas G, Casañ Lopez C, Hernández Á, Bordoy AE, González Soler V, Blanco J, Pradenas E, Marfil S, Trinité B, Piccolo Ferreira F, Bonet M, Cantoni J, Marks M
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