Hana M. El Sahly, MD reviewing Spinner CD et al. JAMA 2020 Aug 21
A 5-day course of remdesivir was associated with a small, but significant, clinical improvement compared with standard care in patients with moderate COVID-19.
Remdesivir (RDV) was recently granted Emergency Use Authorization for patients with severe COVID-19 based on studies showing that time to recovery was decreased with RDV versus placebo (NEJM JW Infect Dis Aug 2020 and N Engl J Med 2020 May 22; [e-pub]) and that a 5-day course was equivalent to a 10-day course in patients who were hypoxic but not mechanically ventilated (NEJM JW Infect Dis Aug 2020 and N Engl J Med 2020 May 27; [e-pub]).
Now, investigators have conducted an industry-sponsored, open-label study to evaluate the efficacy of RDV in 584 patients with moderate disease, defined as those hospitalized with evidence of COVID-19 pneumonia but no hypoxia. Patients were randomized 1:1:1 to receive 10 days of RDV, 5 days of RDV, or standard care (SC). The primary endpoint was clinical status on a 7-point ordinal scale, ranging from 1 (death) to 7 (discharged), at day 11.
Results were as follows:
76% of the patients in the 5-day RDV group completed therapy, and 38% of patients in the 10-day RDV group completed therapy; the most common reason for discontinuation was discharge from the hospital.
Patients in the 5-day RDV group had a significantly better distribution of clinical status scores than those in the SC group (odds ratio, 1.65); patients in the 10-day RDV group had nonsignificantly better distribution of scores than those in the SC group.
There were no significant differences between groups in the exploratory endpoints of time to recovery, time to improvement in clinical status, or death at 28 days.
Patients in the 10-day RDV group were significantly more likely to have adverse events than those in the SC group.
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