BACKGROUND AND PURPOSE:

• In a controlled trial, remdesivir provided a clinical benefit to patients with severe COVID-19
• Spinner et al. (JAMA, 2020) assessed the efficacy of 5 or 10 days of remdesivir treatment compared with standard care in patients with moderate COVID-19

METHODS:

• Randomized, open-label trial (enrollment from March 15 to April 18, 2020)
• Setting
  • 105 hospitals in the United States, Europe, and Asia
• Participants
  • Hospitalized
  • Confirmed COVID-19
  • Moderate disease: Pulmonary infiltrates and room-air oxygen saturation >94%
• Interventions
  • 10-day course of remdesivir
  • 5-day course of remdesivir
  • Standard care
• Study design
  • 1:1:1 randomization
  • Remdesivir dosing: 200 mg IV on day 1 followed by 100 mg/d
  • Clinical status:  7-point ordinal scale ranging from death (category 1) to discharged (category 7)
  • Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios (OR)
    • An OR greater than 1 indicated difference in clinical status distribution in favor of category 7 
• Primary outcome
  • Clinical status on day 11

RESULTS:

• 583 patients began the study | 91% completion
  • Median age: 57 (IQR 46 to 66) years | 39% women
• Comorbidities
  • Cardiovascular disease: 56%
  • Hypertension: 42%
  • Diabetes: 40%
• Intervention groups
  • 10-day remdesivir: 197 patients
  • 5-day remdesivir: 199 patients
  • Standard care: 200 patients
• Median length of treatment
  • 5-day group: 5 days
  • 10-day group: 6 days
• Patients in the 5-day remdesivir group had significantly higher odds of a better clinical status (day 11) than those receiving standard care (P=0.02)
  • OR 1.65 (95% CI, 1.09 to 2.48)
• No significant difference was seen in clinical status distribution on day 11 between the 10-day remdesivir group and the standard care group (P = 0.18)
• Mortality by day 28
  • 5-day remdesivir: 1% (2 patients)
  • 10-day remdesivir: 2% (3 patients)
  • Standard care: 2% (4 patients)
• Side effects were more common in the remdesivir treated patients vs standard care group for the following
  • Nausea (10% vs 3%)
  • Hypokalemia (6% vs 2%)
  • Headache (5% vs 3%)

CONCLUSION:

• For patients with moderate COVID-19, a 10-day course of remdesivir had no significant impact on clinical status at day 11, compared to standard care
• However, for a shorter course, authors conclude that

Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance

Learn More – Primary Sources:

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19 A Randomized Clinical Trial

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