Hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate coronavirus disease 2019 (COVID-19) pneumonia treated with remdesivir did not experience clear clinical improvement compared with standard of treatment alone, according to study results published in the Journal of the American Medical Association.
Patients hospitalized with moderate COVID-19 pneumonia in the United States, Europe, and Asia were randomly assigned 1:1:1 to receive either a 10-day course of remdesivir, a 5-day course of remdesivir, or standard care (ClinicalTrials.gov Identifier: NCT04292730). The primary study outcome was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to being discharged from hospital (category 7).
Of the 596 patients who were randomly assigned to treatment, 533 completed the trial. The median age of participants was 57 years, and 39% were women. 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. In the primary study outcome, 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). However, the difference in clinical status distribution between the 10-day remdesivir and standard care groups was not significant. Nausea, hypokalemia, and headache were more common in the remdesivir groups vs the standard care group.
The study authors noted several limitations, including that the original study protocol was written when COVID-19 was largely confined to Asia and the clinical understanding of the disease came from case series. In addition, the use of an open-label design may have led to biases in patient care and data reporting. The effect of remdesivir on SARS-CoV-2 viral loads was not assessed because of the swift manner in which the study was conducted. Finally, the researchers did not collect other laboratory parameters that may have helped identify other predictors of outcomes.
“Among patients with moderate COVID-19, those [randomly assigned] 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,” the study authors wrote. “Patients [randomly assigned] 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.”
Disclosure: This clinical trial was supported by Gilead. Please see the original reference for a full list of authors’ disclosures.
Spinner CD, Gottlieb RL, Criner GJ, et al; for the GS-US-540-5774 Investigators. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA. Published online August 21, 2020. doi:10.1001/jama.2020.16349