Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients
Millat-Martinez, Pere (Hospital Clínic i Provincial de Barcelona)
Gharbharan, Arvind (University Medical Center)
Alemany, Andrea (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Rokx, Casper (University Medical Center)
Geurtsvankessel, Corine (Erasmus MC)
Papageourgiou, Grigorios (University Medical Center)
van Geloven, Nan (Leiden University Medical Center)
Jordans, Carlijn (University Medical Center)
Groeneveld, Geert (Leiden University Medical Center)
Swaneveld, Francis (Sanquin Blood Supply)
van der Schoot, Ellen (Sanquin Research)
Corbacho-Monné, Marc (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Ouchi, Dan (Universitat Autònoma de Barcelona)
Piccolo Ferreira, Francini (Bioclever-CRO)
Malchair, Pierre (Hospital Universitari de Bellvitge)
Videla, Sebastián (Hospital Universitari de Bellvitge)
García García, Vanesa (Hospital Universitari de Bellvitge)
Ruiz-Comellas, Anna (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Ramírez-Morros, Anna (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Rodriguez Codina, Joana (Hospital de Berga)
Amado Simon, Rosa (Hospital de Berga)
Grifols, Joan-Ramon (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Blanco, Julià (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Blanco Guillermo, Ignacio (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Ara del Rey, Jordi (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Bassat, Quique (Hospital Clínic i Provincial de Barcelona)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Baro, Barbara (Hospital Clínic i Provincial de Barcelona)
Troxel, Andrea (NYU Grossman School of Medicine)
Zwaginga, Jaap Jan (Sanquin Blood Supply)
Mitjà, Oriol (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Rijnders, Bart J. A. (University Medical Center)

Fecha:	2022
Resumen:	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 Clinical studies have suggested that the therapeutic potential of polyclonal convalescent plasma is highest in the first days of symptoms. Here, the authors present results from a pooled analysis of two clinical trials in COVID-19 outpatients that did not provide conclusive evidence in favor of convalescent plasma.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Randomized controlled trials ; SARS-CoV-2 ; Viral infection
Publicado en:	Nature communications, Vol. 13 (may 2022) , ISSN 2041-1723

DOI: 10.1038/s41467-022-29911-3
PMID: 35546145

9 p, 1.4 MB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Instituto de Investigación e Innovación Parc Taulí (I3PT)
Artículos > Artículos de investigación
Artículos > Artículos publicados