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Remdesivir for 5 or 10 Days in Patients With Severe COVID-19
Quick Takes
- Longer treatment with intravenous (10 days) remdesivir was not associated with clinical improvement compared to a shorter treatment period (5 days).
- Until proven otherwise, a 5-day remdesivir regimen should be given to patients at the early stages of severe disease.
Study Questions:
Does treatment with intravenous remdesivir for 10 days compared to 5 days in patients hospitalized with coronavirus disease 2019 (COVID-19) improve clinical status at day 14 of hospitalization?
Methods:
In this open-label, randomized, multicenter trial, hospitalized patients (≥12 years old) with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with radiographic evidence of COVID-19 and oxygen saturation ≤94% or requiring oxygen supplementation were randomized to intravenous remdesivir for 10 days versus 5 days. Patients on mechanical ventilation or extracorporeal membrane oxygenation were excluded. The primary outcome was clinical improvement on day 14 defined by a 7-point ordinal scale ranging from 1: death, to 7: discharge. The secondary endpoint of the trial was the proportion of patients with adverse events that occurred on or after the first dose of remdesivir for up to 30 days after the last dose.
Results:
A total of 397 enrolled patients began treatment: 200 patients were randomized to receive a 5-day course of remdesivir and 197 a 10-day course. Age (median of 61 years), gender (64% male), and race (70% white) were similar between both groups. By day 14, a total of 16 patients (8%) in the 5-day group and 21 patients (11%) in the 10-day group had died, and 120 (60%) and 103 (52%), respectively, had been discharged. In all, 65% of patients who received a 5-day course of remdesivir showed a clinical improvement of ≥2 points on the 7-point ordinal scale at day 14, as compared with 54% of patients who received a 10-day course. After adjusting for baseline clinical status, the difference in clinical improvement was not statistically significant (p = 0.14). Nonstatistically significant trends favoring a 5-day course were noted among secondary endpoints such as mortality, number of patients discharged at 14 days, and proportion of patients who recovered. In post hoc analyses, patients receiving mechanical ventilation or extracorporeal membrane oxygenation at day 5, 40% (10 of 25) in the 5-day group had died by day 14, as compared with 17% (7 of 41) in the 10-day group.
Conclusions:
There was no difference in clinical improvement at 14 days with a 10-day course of remdesivir compared to a 5-day course in patients with COVID-19 not requiring mechanical ventilation.
Perspective:
This open-label trial, concurrently published with the Adaptive Covid-19 Treatment Trial, looks to define the optimal duration of treatment with remdesivir. While there were no significant differences between a 5-day and 10-day course, the conclusion may have been confounded at least partially by the differences in clinical status at baseline, with significantly more patients in the 10-day group who ended up requiring mechanical ventilation prior to initiation of treatment, and a higher number needed high-flow oxygen support. The post hoc analyses reported are hypothesis-generating at best. Overall, if a difference did exist between a 5- and 10-day course of remdesivir, it would be a small and likely clinically insignificant one.
Clinical Topics: COVID-19 Hub, Prevention
Keywords: Coronavirus, Coronavirus Infections, COVID-19, Extracorporeal Membrane Oxygenation, Oxygen Inhalation Therapy, Patient Discharge, Primary Prevention, remdesivir, Respiration, Artificial, severe acute respiratory syndrome coronavirus 2
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