Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma
COVID-19
Convalescent plasma
SARS-CoV-2
Journal
Lancet regional health. Americas
ISSN: 2667-193X
Titre abrégé: Lancet Reg Health Am
Pays: England
ID NLM: 9918232503006676
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
entrez:
21
3
2022
pubmed:
22
3
2022
medline:
22
3
2022
Statut:
ppublish
Résumé
Administration of convalescent plasma may serve as an adjunct to supportive treatment to prevent COVID-19 progression and death. We aimed to evaluate the efficacy and safety of 2 volumes of intravenous convalescent plasma (CP) with high antibody titers for the treatment of severe cases of COVID-19. We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for SARS-CoV2, within 10 days of the symptom onset, were eligible. Patients were randomly assigned (1:1:1) to receive standard of care (SoC) alone, or in combination with 200 mL (150-300 mL) of CP (Low-volume), or 400 mL (300-600 mL) of CP (High-volume); infusion had to be performed within 24 h of randomization. Randomization was centralized, stratified by center. The primary outcome was the time until clinical improvement up to day 28, measured by the WHO ten-point scale, assessed in the intention-to-treat population. Interim and terminal analyses were performed in a Bayesian framework. Trial registered at ClinicalTrials.gov: NCT04415086. Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC ( In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits. Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.
Sections du résumé
Background
UNASSIGNED
Administration of convalescent plasma may serve as an adjunct to supportive treatment to prevent COVID-19 progression and death. We aimed to evaluate the efficacy and safety of 2 volumes of intravenous convalescent plasma (CP) with high antibody titers for the treatment of severe cases of COVID-19.
Methods
UNASSIGNED
We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for SARS-CoV2, within 10 days of the symptom onset, were eligible. Patients were randomly assigned (1:1:1) to receive standard of care (SoC) alone, or in combination with 200 mL (150-300 mL) of CP (Low-volume), or 400 mL (300-600 mL) of CP (High-volume); infusion had to be performed within 24 h of randomization. Randomization was centralized, stratified by center. The primary outcome was the time until clinical improvement up to day 28, measured by the WHO ten-point scale, assessed in the intention-to-treat population. Interim and terminal analyses were performed in a Bayesian framework. Trial registered at ClinicalTrials.gov: NCT04415086.
Findings
UNASSIGNED
Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC (
Interpretation
UNASSIGNED
In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits.
Funding
UNASSIGNED
Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.
Identifiants
pubmed: 35308034
doi: 10.1016/j.lana.2022.100216
pii: S2667-193X(22)00033-3
pmc: PMC8923059
doi:
Banques de données
ClinicalTrials.gov
['NCT04415086']
Types de publication
Journal Article
Langues
eng
Pagination
100216Informations de copyright
© 2022 The Author(s).
Déclaration de conflit d'intérêts
Authors declare no competing interests.
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