Respiratory Trials·org

COVID-19 · Immunomodulation in COVID-19

ACTT-2 randomised trial

Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

ACTT-2 trial design and results
Design Double-blind, randomised, placebo-controlled trial
Treatment Baricitinib plus remdesivir
Control Remdesivir plus placebo
Population 1033 hospitalised adults with COVID-19
Follow-up 29 days
Primary endpoint Time to recovery
Result Median time to recovery was 7 days (95% CI 6 to 8) with baricitinib plus remdesivir versus 8 days with remdesivir alone. Clinical status improved faster, most markedly among patients receiving high-flow oxygen or non-invasive ventilation at enrolment.
Secondary endpoints Clinical status at day 15, mortality, adverse events

Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation.

The trial authors, in the published abstract

How it has aged

A one-day difference in a soft endpoint, on a background of remdesivir whose own benefit is contested. The subgroup on non-invasive support is where the signal concentrates, consistent with REMAP-CAP IL-6: immunomodulation helps when the disease has become inflammatory.

Publications

Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med 2021 Mar 4;384(9):795-807.

  • Median recovery time 7 versus 8 days
  • Largest effect in patients on high-flow oxygen or non-invasive ventilation