COVID-19 · Immunomodulation in critical COVID-19
Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19
| Design | Randomised, embedded, multifactorial adaptive platform trial |
|---|---|
| Treatment | Tocilizumab, or sarilumab |
| Control | Usual care |
| Population | 803 critically ill patients with COVID-19 receiving organ support in intensive care |
| Follow-up | 90 days |
| Primary endpoint | Respiratory and cardiovascular organ support-free days to day 21 |
| Result | Both agents met the predefined efficacy criteria. Median organ support-free days were 10 (IQR -1 to 16) with tocilizumab, 11 (0 to 16) with sarilumab and 0 (-1 to 15) with control. Survival was improved. |
| Secondary endpoints | In-hospital mortality, 90-day survival, time to ICU and hospital discharge |
In critically ill patients with Covid-19 receiving organ support in ICUs, treatment with the interleukin-6 receptor antagonists tocilizumab and sarilumab improved outcomes, including survival.
The trial authors, in the published abstract
Adaptive platform design at its best: two agents evaluated simultaneously against a shared control, stopped as soon as the efficacy criteria were met. Together with RECOVERY dexamethasone it defined the immunomodulatory approach to severe COVID-19.
Gordon AC, Mouncey PR, Al-Beidh F, et al. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. N Engl J Med 2021 Apr 22;384(16):1491-1502.