Dataset Information

Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI).

ABSTRACT:

Background

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

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

Between June 2, 2020, and November 18, 2020, 129 patients were enrolled and randomly assigned to SoC (n = 42), Low-volume (n = 43) or High-volume (n = 44) CP. Donors presented a median titer of neutralizing antibodies of 1:320 (interquartile range, 1:160 to 1:1088). No evidence of any benefit of convalescent plasma was observed, with Bayesian estimate of 28-day clinical improvement of 72.7% (95%CI, 58.8 to 84.7) in the SoC versus 64.1% (95%ci, 53.8 to 73.7) in the pooled experimental groups (mean difference of -8.7%, 95%CI, -24.6 to 8.2). There was one case of cutaneous mild allergic reaction related to plasma transfusion and one case of suspected transfusion-related acute lung injury but deemed not to be related to convalescent plasma infusion.

Interpretation

In this prospective, randomized trial of adult hospitalized patients with severe COVID-19, convalescent plasma was not associated with clinical benefits.

Funding

Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.

SUBMITTER: Song ATW

PROVIDER: S-EPMC8923059 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma <i>versus</i> standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI).

Song Alice T W ATW Rocha Vanderson V Mendrone-Júnior Alfredo A Calado Rodrigo T RT De Santis Gil C GC Benites Bruno D BD Costa-Lima Carolina C Vargas Taiani T Marques Leonardo S LS Fernandes Juliana C JC Breda Felipe C FC Wendel Silvano S Fachini Roberta R Rizzo Luiz V LV Kutner José Mauro JM Avelino-Silva Vivian I VI Machado Rafael R G RRG Durigon Edison L EL Chevret Sylvie S Kallas Esper G EG

Lancet regional health. Americas 20220315

<h4>Background</h4>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.<h4>Methods</h4>We conducted a Bayesian, randomized, open-label, multicenter, controlled clinical trial in 7 Brazilian hospitals. Adults admitted to hospital with positive RT-PCR for ...[more]

PMID: 35308034

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