Study Finds Remdesivir Benefits Patients with COVID-19, Results in Greater Clinical Improvement
The FDA granted an Emergency Use Authorization for the drug in hospitalized patients with severe COVID-19, but the authorization does not take the place of a formal new drug approval process.
Patients with coronavirus disease 2019 (COVID-19) who received a 5-day course of remdesivir were 65% more likely to show clinical improvement at day 11, compared with patients who received only standard of care according to phase 3 findings of the SIMPLE trial.1
Remdesivir is currently approved in Japan for patients infected with Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), and is an investigational, unapproved drug in other countries. The FDA granted an Emergency Use Authorization for the drug in hospitalized patients with severe COVID-19, but the authorization does not take the place of a formal new drug approval process.1
In the new study, hospitalized patients with a confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized to receive open-label remdesivir for 5 or 10 days or standard of care alone.1
At evaluation on day 11, more patients in the 5-day treatment group achieved improvement than in the standard of care group. Furthermore, the investigators observed non-statistically significant increases in clinical worsening or death among the patients who received only standard of care.1
“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, in a statement. “These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”1
This new data comes after the leaked results of a remdesivir study in China found no benefits in patients. According to reporting by STAT, the World Health Organization mistakenly posted a draft manuscript, which was taken down once the mistake was noticed. Gilead challenged the results and said they were “inconclusive” because the trial was ended early and had low enrollment.2
According to STAT, the accidentally released results found that after 1 month, 13.9% of patients who received the drug died compared with 12.8% of patients in the control arm. These are not the only studies, however, and other ongoing investigations include various control arms and courses of treatment.2
According to a statement from Gilead, these results mark the third randomized, controlled clinical trial demonstrating that remdesivir resulted in improved clinical outcomes.3 A placebo-controlled study by the National Institute of Allergy and Infectious Diseases found that the drug enabled a faster recovery and that earlier treatment resulted in improved outcomes in patients with a range of disease severity.3 Similarly, the earlier SIMPLE-Severe study results found that in patients with severe COVID-19, 5 days of remdesivir led to similar improvements as a 10-day course of treatment.3
“The additional data we have in hand today will further guide our research efforts, including evaluating treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, pediatric studies, and the development of alternate formulations,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, in the statement.1
- Gilead Announces Results from Phase 3 Trial of Remdesivir in Patients with Moderate COVID-19 [news release]. Gilead Sciences; June 1, 2020. https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-announces-results-from-phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19. Accessed June 1, 2020.
- Silverman E, Feuerstein A, and Herper M. New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope. STAT; April 23, 2020. https://www.statnews.com/2020/04/23/data-on-gileads-remdesivir-released-by-accident-show-no-benefit-for-coronavirus-patients/. Accessed June 1, 2020.
- Gilead Sciences Statement on Remdesivir Clinical Data [news release]. Gilead Sciences; June 1, 2020. https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-remdesivir-clinical-data. Accessed June 1, 2020.