Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.

Abstract (PubMed)

Severe coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known. We conducted a double-blind, randomized, placebo-controlled trial (ACTT-2) evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15. A total of 1033 patients underwent randomization (515 to combination, 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% CI, 6 to 8) vs 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P=0.03). 28-day mortality was 5.1% vs 7.8% (HR 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group (16.0% vs. 21.0%; P=0.03). Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating clinical status improvement, notably in patients on high-flow oxygen or noninvasive ventilation.