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0 0.5 1 1.5 2+ Mortality -51% Improvement Relative Risk Higgins et al. NCT02735707 REMAP-CAP HCQ RCT ICU Favors HCQ Favors control
Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial
Higgins et al., JAMA, doi:10.1001/jama.2022.23257, REMAP-CAP, NCT02735707 (history)
Higgins et al., Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical.., JAMA, doi:10.1001/jama.2022.23257, REMAP-CAP, NCT02735707
Dec 2022   Source   PDF  
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Long-term followup for the REMAP-CAP very late stage ICU trial, showing higher risk with HCQ, not quite reaching statistical significance.
risk of death, 51.0% higher, HR 1.51, p = 0.06, treatment 16 of 41 (39.0%), control 107 of 311 (34.4%), adjusted per study, day 180.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Higgins et al., 16 Dec 2022, Randomized Controlled Trial, multiple countries, peer-reviewed, 1896 authors, study period 9 March, 2020 - 22 June, 2021, trial NCT02735707 (history) (REMAP-CAP).
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Abstract: Research JAMA | Original Investigation | CARING FOR THE CRITICALLY ILL PATIENT Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial Writing Committee for the REMAP-CAP Investigators Editorial IMPORTANCE The longer-term effects of therapies for the treatment of critically ill patients with COVID-19 are unknown. Supplemental content 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 probabilities of harm from hydroxychloroquine (96.9%; HR, 1.51 [95% CrI, 0.98-2.29]) and the combination of lopinavir-ritonavir and hydroxychloroquine (96.8%; HR, 1.61 [95% CrI, 0.97-2.67]) were high. The corticosteroid domain was stopped early prior to reaching a predefined statistical trigger; there was a 57.1% to 61.6% probability of improving 6-month survival across varying hydrocortisone dosing strategies. CONCLUSIONS AND RELEVANCE Among critically ill patients with COVID-19 randomized to receive 1 or more therapeutic interventions, treatment with an IL-6 receptor antagonist had a greater than 99.9% probability of improved 180-day mortality compared with patients randomized to the control, and treatment with an antiplatelet had a 95.0% probability of improved 180-day mortality compared with patients randomized to the control. Overall, when considered with previously reported short-term results, the findings indicate that initial in-hospital treatment effects were consistent for most therapies through 6 months. Group Information: The authors/members of the writing committee for the REMAP-CAP Investigators appears listed at the end of this article and the full list..
Late treatment
is less effective
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