Review: Remdesivir for 5 or 10 days in patients with severe COVID-19

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Review: Remdesivir for 5 or 10 days in patients with severe COVID-19

Review: Remdesivir for 5 or 10 days in patients with severe COVID-19

This randomized, open-label trial found no significant difference in defined clinical outcomes between a 5 day vs 10 day course of remdesivir. 

  • Inclusion criteria: >11 years of age, confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia.
  • Study participants enrolled at 55 hospitals in the United States, Italy, Spain, Germany, Hong Kong, Singapore, South Korea, and Taiwan between March 6 and March 26, 2020.
  • Patients were randomly assigned in a 1:1 ratio to receive intravenous treatment with remdesivir for 5 days or 10 days. The randomization was not stratified. No control group was utilized.
  • All the patients were to receive 200 mg of remdesivir on day 1, followed by 100 mg of remdesivir once daily for the subsequent 4 or 9 days.
  • The primary efficacy end point was clinical status assessed on day 14 on a 7-point ordinal scale
  • Of the 408 patients who were assessed for eligibility, 402 were enrolled and underwent randomization and 397 began treatment: 200 patients were assigned to receive a 5-day course of remdesivir and 197 a 10-day course
    • Of those who did not complete the 5-day course of treatment, reasons included hospital discharge (16 patients [8%]) and adverse events (9 [4%])
    • Of those who did not complete the 10-day course, reasons included hospital discharge (68 patients [35%]), adverse events (22 [11%]), and death (12 [6%])
    • The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%).
  • At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P=0.02).
  • After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P=0.14).
|2020-05-29T11:16:40-04:00May 28th, 2020|COVID-19 Literature|0 Comments

About the Author: Megan McHenry

Megan McHenry
Megan S. McHenry, MD, MS, FAAP is a pediatrician and an Assistant Professor of Pediatrics in the Ryan White Center for Pediatric Infectious Disease and Global Health at Indiana University School of Medicine. Dr. McHenry's research focuses on early childhood development in children living in resource-limited settings. This work is frequently aligned with community-engaged research and dissemination and implementation science frameworks. She primarily conducts research in collaboration with the Academic Model for Providing Access to Healthcare (AMPATH) Research Network in Kenya. Dr. McHenry currently has a career development award through the National Institutes of Health to develop a neurodevelopmental screening program for children born to HIV-infected mothers in Kenya. Dr. McHenry is also the Director of Pediatric Global Health Education and a co-Director of the Morris Green Physician-Scientist Development Program at Indiana University School of Medicine. In additional to global health lectures, she also educates residents and students on early childhood development, basic biostatistical techniques, research methodologies, and research ethics. She mentors multiple pediatric fellows, residents, and medical students interested in early childhood development within global contexts.

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