Remdesivir vs. Standard Care in Patients With Moderate COVID-19 - Remdesivir for Moderate COVID-19

Aug 24, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Supplemental Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Gilead Sciences
Date Published:
08/21/2020
Date Updated:
08/24/2020
Original Posted Date:
08/24/2020
References

Contribution To Literature:

This trial showed that a 5-day course of remdesivir was superior to standard therapy at improving clinical status. 

Description:

The goal of the trial was to evaluate remdesivir compared with standard therapy among patients with moderate coronavirus disease 2019 (COVID-19) infection. Previous evaluation found that remdesivir was beneficial treatment for patients with severe COVID-19 infection.


Study Design

  • Randomized
  • Parallel
  • Open-label

Patients who met enrollment criteria were randomized to remdesivir for 10 days (n = 197) versus remdesivir for 5 days (n = 199) versus standard therapy (n = 200). Remdesivir was given intravenously 200 mg on day 1, then 100 mg daily.

  • Total number of enrollees: 596
  • Duration of follow-up: 14 days
  • Mean patient age: 57 years
  • Percentage female: 39%
  • Percentage with diabetes: 40%

Inclusion criteria:

  • COVID-19 infection
  • Moderate pneumonia (pulmonary infiltrates and room air oxygen saturation >94%)

Exclusion criteria:

  • Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of normal
  • Creatinine clearance <50 ml/min

Other salient features/characteristics:

The primary outcome was a 7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen or ongoing medical care; and 7, not hospitalized.

Principal Findings:

The primary outcome, favorable clinical status distribution on day 11, was increased in the remdesivir 5-day group versus the standard care group (odds ratio 1.65, 95% confidence interval p < 0.001). Favorable clinical status distribution on day 11 was similar in the remdesivir 10-day group versus the standard care group (p = 0.18).

Secondary outcomes:

  • Discontinuation of study drug because of an adverse event: 4% in the 10-day remdesivir group versus 2% in the 5-day remdesivir group (p = nonsignificant)

Interpretation:

Among patients infected with COVID-19 and with moderate pneumonia, a 5-day course of remdesivir was associated with improved clinical status compared with standard therapy. A 10-day course or remdesivir was not associated with a statistical difference compared with standard therapy. The clinical significance of the finding in the 5-day remdesivir group is unknown. The open-label design of the trial could have led to study bias.

References:

Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA 2020;Aug 21:[Epub ahead of print].

Clinical Topics: COVID-19 Hub, Prevention

Keywords: Coronavirus, COVID-19, Extracorporeal Membrane Oxygenation, Noninvasive Ventilation, Oxygen, Pneumonia, Primary Prevention, remdesivir, remdesivir, Respiration, Artificial, severe acute respiratory syndrome coronavirus 2, Ventilation


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