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).
