Effect of convalescent plasma on organ support-free days in critically patients with COVID-19: A Randomized Clinical Trial.

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Abstract

Abstract
IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.
OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19.
DESIGN, SETTING AND PARTICIPANTS. An ongoing adaptive platform trial (REMAP-CAP). Between March 9 2020 and January 18, 2021, 4,763 adults with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended April 19, 2021.
INTERVENTIONS The immunoglobulin domain randomized participants to receive two units of high-titer ABO-compatible convalescent plasma (total volume 550ml ± 150ml) within 48 hours of randomization (n=1084), or no convalescent plasma (n=916).
MAIN OUTCOMES AND MEASURES The primary ordinal endpoint was organ support-free days (days alive and free of ICU-based organ-support) up to day 21(range -1 to 21 days; patients who died were assigned –1 day). The primary analysis was an adjusted Bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) > 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR < 1.2 (threshold for trial conclusion of futility >95%). An OR> 1 represented improved survival, more organ support–free days, or both.
RESULTS Among the 2,011 participants who were randomized (median age 61 years, and 645 (32.3%) women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the pre-specified criterion for futility was met. For convalescent plasma vs no convalescent plasma, respectively, the median organ support–free days were 0 (IQR, –1 to 16), and 3 (IQR, –1 to 16), respectively. This was composed of in-hospital mortality of 37.3% (403/1075) and 38.4% (401/1075), and median days alive and free of organ support of 14 (IQR 3 to 18) and 14 (IQR 7 to 18), respectively. The median adjusted OR was 0.97 (95% credible interval 0.83 to 1.15) and posterior probability of futility (OR < 1.2) was 99.4% for convalescent plasma compared to no convalescent plasma. Treatment effects were consistent across the primary and eleven secondary outcomes. Serious adverse events were reported in 32/1075 (3%), and 12/905 (1.3%) participants in the convalescent plasma and no convalescent plasma groups, respectively.
CONCLUSIONS AND RELEVANCE In critically ill adults with confirmed COVID-19, treatment with two units of high-titer ABO-compatible convalescent plasma, had a low likelihood of providing improvement in organ support-free days.TRIAL REGISTRATION Clinicaltrials.gov: NCT02735707 
Original languageEnglish
JournalJAMA - Journal of the American Medical Association
Publication statusAccepted/In press - 24 Sep 2021

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