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#Grand Rounds

RCT Results: Does Remdesivir Improve Clinical Status in Patients with Moderate COVID-19?

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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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Related ObG Topics:

Remdesivir for COVID-19: RCT Results from 10 Hospitals in China
ACTT-1 Remdesivir RCT: Preliminary Results Now Published
Prospective Trial Results (France): Hydroxychloroquine and Azithromycin Provide No Clinical Benefit for COVID-19

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