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)
Alice T W Song, Vanderson Rocha, Alfredo Mendrone-Júnior, Rodrigo T Calado, Gil C De Santis, Bruno D Benites, Carolina Costa-Lima, Taiani Vargas, Leonardo S Marques, Juliana C Fernandes, Felipe C Breda, Silvano Wendel, Roberta Fachini, Luiz V Rizzo, José Mauro Kutner, Vivian I Avelino-Silva, Rafael R G Machado, Edison L Durigon, Sylvie Chevret, Esper G Kallas
The Lancet Regional Health - Americas, doi:10.1016/j.lana.2022.100216
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.
TV, LSM, JCF, CSL, and FCB led the implementation of the study. SC did the statistical plan and analysis and SC, ATWS, VIAS, NBC, and DGA have verified the underlying data. RRGM, ELD, CPS, RM, DBA, CSL, and EDC generated laboratory data. ATWS, VR, SC, VIAS, and EGK drafted the report. All other authors contributed to the implementation and data collection. All authors reviewed and approved the final report. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Supplementary materials Supplementary material associated with this article can be found in the online version at doi:10.1016/j. lana.2022.100216.
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