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Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial

Title: Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial
Authors: Florescu, Simin; Stanciu, Delia; Zaharia, Mihaela; Kosa, Alma; Codreanu, Daniel; Kidwai, Aneela; Masood, Sobia; Kaye, Callum; Coutts, Amanda; MacKay, Lynn; Summers, Charlotte; Polgarova, Petra; Farahi, Neda; Fox, Eleonore; McWilliam, Stephen; Hawcutt, Daniel; Rad, Laura; O’Malley, Laura; Whitbread, Jennifer; Jones, Dawn; Dore, Rachael; Saunderson, Paula; Kelsall, Olivia; Cowley, Nicholas; Wild, Laura; Thrush, Jessica; Wood, Hannah; Austin, Karen; Bélteczki, János; Magyar, István; Fazekas, Ágnes; Kovács, Sándor; Szőke, Viktória; Donnelly, Adrian; Kelly, Martin; Smyth, Naoise; O’Kane, Sinéad; McClintock, Declan; Warnock, Majella; Campbell, Ryan; McCallion, Edmund; Azaiz, Amine; Charron, Cyril; Godement, Mathieu; Geri, Guillaume; Vieillard-Baron, Antoine; Johnson, Paul; McKenna, Shirley; Hanley, Joanne; Currie, Andrew
Source: JAMA ; volume 329, issue 1, page 39 ; ISSN 0098-7484
Publisher Information: American Medical Association (AMA)
Publication Year: 2023
Description: Importance The longer-term effects of therapies for the treatment of critically ill patients with COVID-19 are unknown. Objective To determine the effect of multiple interventions for critically ill adults with COVID-19 on longer-term outcomes. Design, Setting, and Participants Prespecified secondary analysis of an ongoing adaptive platform trial (REMAP-CAP) testing interventions within multiple therapeutic domains in which 4869 critically ill adult patients with COVID-19 were enrolled between March 9, 2020, and June 22, 2021, from 197 sites in 14 countries. The final 180-day follow-up was completed on March 2, 2022. Interventions Patients were randomized to receive 1 or more interventions within 6 treatment domains: immune modulators (n = 2274), convalescent plasma (n = 2011), antiplatelet therapy (n = 1557), anticoagulation (n = 1033), antivirals (n = 726), and corticosteroids (n = 401). Main Outcomes and Measures The main outcome was survival through day 180, analyzed using a bayesian piecewise exponential model. A hazard ratio (HR) less than 1 represented improved survival (superiority), while an HR greater than 1 represented worsened survival (harm); futility was represented by a relative improvement less than 20% in outcome, shown by an HR greater than 0.83. Results Among 4869 randomized patients (mean age, 59.3 years; 1537 [32.1%] women), 4107 (84.3%) had known vital status and 2590 (63.1%) were alive at day 180. IL-6 receptor antagonists had a greater than 99.9% probability of improving 6-month survival (adjusted HR, 0.74 [95% credible interval {CrI}, 0.61-0.90]) and antiplatelet agents had a 95% probability of improving 6-month survival (adjusted HR, 0.85 [95% CrI, 0.71-1.03]) compared with the control, while the probability of trial-defined statistical futility (HR >0.83) was high for therapeutic anticoagulation (99.9%; HR, 1.13 [95% CrI, 0.93-1.42]), convalescent plasma (99.2%; HR, 0.99 [95% CrI, 0.86-1.14]), and lopinavir-ritonavir (96.6%; HR, 1.06 [95% CrI, 0.82-1.38]) and the ...
Document Type: article in journal/newspaper
Language: English
DOI: 10.1001/jama.2022.23257
Availability: https://doi.org/10.1001/jama.2022.23257; https://jamanetwork.com/journals/jama/articlepdf/2799870/jama_higgins_2022_oi_220139_1671563398.8122.pdf
Accession Number: edsbas.B71529D
Database: BASE