Clinical Research and Quality Improvement
Remdesivir for COVID-19: A ray of hope?
The year 2020 witnessed a pandemic of unprecedented proportions, caused by a novel corona virus strain (SARS-CoV2). Across the globe, there have been more than 6.5 million positive cases of COVID-19 and more than 380,000 deaths. (WHO COVID-19 Dashboard [https://covid19.who.int]). Multiple therapeutic agents are currently being studied as potential treatment options for this novel disease. With negative trials so far on lopinavir-ritonavir and hydroxychloroquine, the only candidate drug showing benefit is remdesivir.
Dr. Aravind Menon
Results of the randomized double-blind placebo controlled Adaptive COVID-19 Treatment Trial (ACTT-1) trial (Beigel, J et al. N Engl J Med. 2020; e-pub ahead of print) shows remdesivir improved recovery time in COVID -19 patients as compared with control subjects. Remdesivir is an inhibitor of viral RNA polymerase that has been shown to inhibit coronaviruses in animal models and SARS-CoV2 in-vitro. The ACTT-1 trial enrolled 1,063 patients with 541 assigned to the remdesivir arm and 522 to the placebo group. Primary outcome measure was time to recovery. Mortality at 14 and 28 days and incidence of adverse events were also evaluated.
As interim analysis showed positive results, the data safety and monitoring board recommended early termination of the trial. Patients in the remdesivir group had a shorter time to recovery, with median recovery time of 11 days as compared with 15 days in placebo group (95% CI:1.12-1.55; P < .001). Hospitalized patients requiring supplemental oxygen (but not high-flow, mechanical ventilation or ECMO) derived the maximum benefit with a rate ratio of recovery being 1.47(95% CI:1.17-1.84). Thus, early drug administration may be beneficial. The difference in mortality at 14 days was not statistically significant and data on mortality difference at 28 days were not available at the time of publication.
In summary, this trial along with previous publications shows that remdesivir is a potential therapeutic option for COVID -19. The Food and Drug Administration (FDA) approved remdesivir under Emergency Use Authorization (EUA) for COVID-19 and larger trials are currently underway to study the full effect of this agent.
Aravind Menon, MD
Fellow-in-Training Member