BACKGROUND AND PURPOSE:

• Beigel et al. (NEJM, 2020) describe results from the first stage of the Adaptive Covid-19 Treatment Trial (ACTT-1), evaluating treatment with remdesivir vs placebo

METHODS:

• Double-blind, randomized, placebo-controlled trial
• Setting
  • 60 trial sites across the Europe, Asia, and North America
• Participants
  • Adults hospitalized with COVID-19
  • Evidence of lower respiratory tract infection
• Interventions
  • Remdesivir
    • 200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days
  • Placebo
• Primary outcome
  • Time to recovery (discharge or hospitalization for infection-control purposes only)
  • Defined as the first day of recovery, during the 28 days after enrollment
• Secondary outcome
  • Clinical status at day 15

RESULTS:

• Remdesivir: 541 patients | Placebo: 521 patients
• Patients who received remdesivir had a shorter median recovery time
  • Remdesivir: median 10 days (95% CI, 9 to 11)
  • Placebo: median 15 days (95% CI, 13 to 18)
  • Rate ratio for recovery: 1.29 (95% CI, 1.12 to 1.4); P<0.001
• Patients who received remdesivir were more likely to have clinical improvement at day 15 (adjusted for disease severity)
  • Odds ratio 1.5 (95% CI, 1.2 to 1.9)
• Benefit “most apparent in patients with a baseline ordinal score of 5 (receiving low-flow oxygen)”
• Mortality (estimated using Kaplan–Meier estimation analysis)
  • By day 15
    • Remdesivir: 6.7%
    • Placebo: 11.9%
  • By day 29
    • Remdesivir: 11.4%
    • Placebo: 15.2%
  • Hazard ratio 0.73 (95% CI, 0.52 to 1.03)
• Serious adverse events
  • Remdesivir: 24.6%
  • Placebo: 31.6%

CONCLUSION:

• For adults with COVID-19 and evidence of lower respiratory tract infection, remdesivir was associated with a shorter time to recovery (by approximately 5 days)
• While benefit was primarily in patients on low-flow oxygen, the authors caution that this does not necessarily mean there is no benefit in other categories (i.e., no oxygen, high-flow oxygen, mechanical ventilation or ECMO)  
• The authors also state that

Our data also suggest that treatment with remdesivir may have prevented the progression to more severe respiratory disease, as shown by the lower proportion of serious adverse events due to respiratory failure among patients in the remdesivir group

Learn More – Primary Sources:

Remdesivir for the Treatment of Covid-19 — Final Report

Related ObG Topics:

Remdesivir Emergency Authorization: FDA Update and Summary of Preliminary NIH Study Data

ACTT-1 Remdesivir RCT: Preliminary Results Now Published

Remdesivir for COVID-19: RCT Results from 10 Hospitals in China