Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial

Writing Committee for the REMAP-CAP Investigators, Lise J Estcourt, Alexis F Turgeon, Zoe K McQuilten, Bryan J McVerry, Farah Al-Beidh, Djillali Annane, Yaseen M Arabi, Donald M Arnold, Abigail Beane, Philippe Bégin, Wilma van Bentum-Puijk, Lindsay R Berry, Zahra Bhimani, Janet E Birchall, Marc J M Bonten, Charlotte A Bradbury, Frank M Brunkhorst, Meredith Buxton, Jeannie L CallumMichaël Chassé, Allen C Cheng, Matthew E Cove, James Daly, Lennie Derde, Michelle A Detry, Menno De Jong, Amy Evans, Dean A Fergusson, Matthew Fish, Mark Fitzgerald, Claire Foley, Herman Goossens, Anthony C Gordon, Iain B Gosbell, Cameron Green, Rashan Haniffa, Heli Harvala, Alisa M Higgins, Thomas E Hills, Veronica C Hoad, Christopher Horvat, David T Huang, Cara L Hudson, Nao Ichihara, Emma Laing, Abigail A Lamikanra, François Lamontagne, Patrick R Lawler, Jennifer Rynne, Manu Shankar-Hari

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, 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 on April 19, 2021. Interventions: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). Main Outcomes and Measures: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-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) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. Results: Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 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 the posterior probability of futility (OR
Original languageEnglish
Pages (from-to)1690-1702
Number of pages13
JournalJournal of the American Medical Association
Issue number17
Early online date4 Oct 2021
Publication statusPublished - 2 Nov 2021


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