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

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, NCT0458...

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Vydané v:Nature communications Ročník 13; číslo 1; s. 2583 - 9
Hlavní autori: Millat-Martinez, Pere, Gharbharan, Arvind, Alemany, Andrea, Rokx, Casper, Geurtsvankessel, Corine, Papageorgiou, Grigorios, van Geloven, Nan, Jordans, Carlijn, Groeneveld, Geert, Swaneveld, Francis, van der Schoot, Ellen, Corbacho-Monné, Marc, Ouchi, Dan, Piccolo Ferreira, Francini, Malchair, Pierre, Videla, Sebastian, García García, Vanesa, Ruiz-Comellas, Anna, Ramírez-Morros, Anna, Rodriguez Codina, Joana, Amado Simon, Rosa, Grifols, Joan-Ramon, Blanco, Julian, Blanco, Ignacio, Ara, Jordi, Bassat, Quique, Clotet, Bonaventura, Baro, Bàrbara, Troxel, Andrea, Zwaginga, Jaap Jan, Mitjà, Oriol, Rijnders, Bart J. A.
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: London Nature Publishing Group UK 11.05.2022
Nature Publishing Group
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Bayes Theorem
Bayesian analysis
Clinical trials
Coronaviruses
COVID-19
COVID-19 - therapy
COVID-19 Serotherapy
Data analysis
Death
Fatalities
Hospitalization
Humanities and Social Sciences
Humans
IgG antibody
Immunization, Passive
Immunoglobulin G
Mechanical ventilation
Meta-analysis
Middle Aged
Mortality
Multicenter Studies as Topic
multidisciplinary
Outpatients
Patients
Plasma
Randomized Controlled Trials as Topic
SARS-CoV-2
Science
Science (multidisciplinary)
Signs and symptoms
Treatment Outcome
ISSN:2041-1723, 2041-1723
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Shrnutí: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 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.
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ISSN:2041-1723
2041-1723
DOI:10.1038/s41467-022-29911-3