The objective of this randomised, open-label trial, recently published in JAMA, was to determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment in patients with moderate COVID-19 infection. Patients with confirmed -CoV-2 infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) were enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. Patients were randomised in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d. The primary end point was clinical status on day 11 on a 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. An odds ratio greater than 1 indicates a difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group. Among 596 patients who were randomised, 584 began the study and received remdesivir or continued standard care, and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea, hypokalaemia, and headache were more frequent among remdesivir-treated patients compared with standard care. The authors concluded that among patients with moderate COVID-19, those randomised to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomised 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.
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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