Journal article

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Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19 A Randomized Clinical Trial

Author(s): Spinner CD, Gottlieb RL, Criner GJ et al

JAMA. Published online August 21 2020

Respiratory infections
General respiratory patient care
Public health

Digest Author(s): Stylianos Loukides, e-Learning Director / 23 August, 2020

As of August 10, 2020, coronavirus disease 2019 (COVID-19), the disease caused by SARS-CoV-2, resulted in more than 730 000 deaths worldwide. Unfortunately, the disease is lacking specific and effective treatment, while the vaccine is still under investigation. Remdesivir is a nucleotide prodrug whose active metabolite inhibits viral RNA-dependent RNA polymerases. Structurally conserved enzymes that play a key role in the replication of a broad range of viruses, including Coronaviruses.

Previous clinical trials have clearly addressed that Remdesivir has a minor clinical benefit mainly attributed to shorted duration of hospitalization, but without affecting mortality. In the current study the authors randomized 596 patients in a 1:1:1 ratio to receive up to a 5-day course of remdesivir, up to a 10-day course of remdesivir, or standard care. The median age was 57 years and 227 (39%) were women. 56% had cardiovascular disease, 42% hypertension, and 40% diabetes, and 533 (91%) completed the trial.

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).

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. Interenstingly by day 14, the clinical status of the 5-day and 10-day remdesivir groups was significantly different than that of the standard care group. By day 28, clinical status remained significantly different in the 10-day remdesivir group compared with standard care. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.

The authors finally concluded that hospitalized patients with moderate COVID-19 randomized to a 5-day course of remdesivir had a statistically significantly better clinical status compared with those randomized to standard care at 11 days after initiation of treatment, but the difference was of uncertain clinical importance.

Comments:

  • It is quite difficult to consider the above study as a positive one. There are many statistical based concerns which need better clarification.
  • At the moment, besides remdesivir no other treatment intervention is currently existend.
  • What we need to do is to improve our standard of care intervention and to focus on an effective vaccine.