ICU sedation, delirium & recovery
Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial
- Corticosteroid domain stopped early prior to reaching a predefined statistical trigger
Authors' conclusion
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.
Study context
- Population
- Critically ill adults with COVID-19, 197 sites in 14 countries, enrolled March 9, 2020–June 22, 2021
- Comparison
- Interventions within 6 treatment domains vs control
- Immune modulatorsn = 2,274
- Convalescent plasman = 2,011
- Antiplatelet therapyn = 1,557
- Anticoagulationn = 1,033
- Antiviralsn = 726
- Corticosteroidsn = 401
- Primary endpoint
- Survival through day 180 (HR <1 = superiority; HR >1 = harm; futility = HR >0.83)
- Follow-up
- Day 180
Methodological detailsprespecified secondary analysis, adaptive platform trial, multicentre, bayesian piecewise exponential model, Final 180-day follow-up completed on March 2, 2022
- Prespecified secondary analysis
- Adaptive platform trial
- Multicentre
- Bayesian piecewise exponential model
- Final 180-day follow-up completed on March 2, 2022
Primary result
As reported in the abstract
Survival through day 180 · 180 days
Each group vs controlEstimate (95% CrI)
IL-6 receptor antagonists>99.9% probability of improving 6-month survival
adjusted HR for death (HR<1 = improved survival) 0.74(0.61–0.90)
Antiplatelet agents95% probability of improving 6-month survival
adjusted HR for death (HR<1 = improved survival) 0.85(0.71–1.03)
Therapeutic anticoagulation99.9% probability of futility (HR >0.83)
HR for death (HR<1 = improved survival) 1.13(0.93–1.42)
Convalescent plasma99.2% probability of futility (HR >0.83)
HR for death (HR<1 = improved survival) 0.99(0.86–1.14)
Lopinavir-ritonavir96.6% probability of futility (HR >0.83)
HR for death (HR<1 = improved survival) 1.06(0.82–1.38)
- Corticosteroids (domain stopped early): probability of improving 6-month survival across hydrocortisone dosing strategies
- 57.1% to 61.6%
Safety
| Outcome | HR for death (HR>1 = worsened survival) (95% CrI) | |
|---|---|---|
| Probability of harm (worsened 6-month survival) · 180 daysHydroxychloroquine vs Control · 96.9% probability of harm · CrI | 1.51 (0.98–2.29) | |
| Probability of harm (worsened 6-month survival) · 180 daysLopinavir-ritonavir + hydroxychloroquine vs Control · 96.8% probability of harm · CrI | 1.61 (0.97–2.67) | |
| 0.20.5125HR for death (HR>1 = worsened survival) (log scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial. JAMA. Published 3 January 2023. doi:10.
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