article257

ACTT-1

"Remdesivir for the Treatment of Covid-19 — Final Report". The New England Journal of Medicine. DOI: 10.1056/NEJMoa2007764.

Clinical Question

Does intravenous remdesivir expedite recovery in adults hospitalized with Covid-19 and lower respiratory tract infection compared to placebo?

Bottom Line

Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.

Major Points

Remdesivir, an antiviral drug, was found to accelerate the recovery of hospitalized adults with Covid-19 compared to placebo, reducing the median recovery time from 15 days to 10 days. The study also suggested that remdesivir may prevent progression to severe respiratory disease.

Guidelines

The FDA issued an Emergency Use Authorization for remdesivir for the treatment of Covid-19 in adults and children hospitalized with suspected or laboratory-confirmed Covid-19. This has been modified and granted full or conditional approval in other countries since that time.

Design

- Multicenter, double-blind, randomized, placebo-controlled trial
- N=1,062 patients with recent confirmation of Covid-19 and lower respiratory tract infection
- Intervention: Remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) (n=541)
- Control: Placebo for up to 10 days (n=521)
- Setting: 60 trial sites and 13 subsites across 10 countries
- Enrollment: February 21 to April 19, 2020
- Analysis: Modified intention-to-treat
- Primary Outcome: Time to recovery by day 29

Population

- Adult patients hospitalized with Covid-19
- Categorized as having mild-to-moderate (15.0%) or severe disease (85.0%)

Interventions

- Remdesivir: 200 mg intravenously on day 1, followed by 100 mg daily for up to 9 additional days
- Control group received a matching placebo

Outcomes

- Primary: Time to recovery (median of 10 days for remdesivir vs. 15 days for placebo)
- Secondary: Clinical status at day 15, mortality at days 15 and 29, use of health care resources
- Mortality at day 15 was 6.7% for remdesivir and 11.9% for placebo; day 29 was 11.4% for remdesivir and 15.2% for placebo

Criticisms

- Treatment with the antiviral drug alone is likely insufficient for all patients
- Mortality reduction was not statistically significant (hazard ratio, 0.73; 95% CI, 0.52 to 1.03)

Funding

National Institute of Allergy and Infectious Diseases (NIAID), other governmental and institutional contributors. Remdesivir provided by Gilead Sciences with no financial support.