COVID-19 Resource Center
COVID-19 Resource Center
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Gilead. Gilead announces results from phase 3 trial of remdesivir in patients with moderate COVID-19. 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 2, 2020.

Disclosures: Parsey is an employee of Gilead. Healio Primary Care was unable to confirm Marty's relevant financial disclosures at the time of publication.
June 02, 2020
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Remdesivir improves moderate COVID-19

Source/Disclosures
Source:

Gilead. Gilead announces results from phase 3 trial of remdesivir in patients with moderate COVID-19. 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 2, 2020.

Disclosures: Parsey is an employee of Gilead. Healio Primary Care was unable to confirm Marty's relevant financial disclosures at the time of publication.
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Patients with moderate COVID-19 who received remdesivir for 5 days were 65% more likely to show clinical improvement compared with those who received usual care, according to results from a phase 3 clinical trial released by the manufacturer.

Previous studies have shown that remdesivir (Gilead Sciences Inc.) may be an effective treatment for patients with COVID-19, and the FDA issued emergency use authorization for remdesivir in hospitalized adults and children with severe COVID-19.

Hospital hall
Patients with moderate COVID-19 who received remdesivir for 5 days were 65% more likely to show clinical improvement compared with those who received usual care, according to results from a phase 3 clinical trial released by the manufacturer.

“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” Francisco Marty, MD, an infectious disease physician at Brigham and Women’s Hospital and an associate professor of medicine at Harvard Medical School, said in a press release. “These study results oer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can signicantly improve clinical outcomes for these patients.”

In the open-label study, Marty and colleagues randomly assigned patients who were hospitalized with confirmed COVID-19 and showed signs of pneumonia to receive the investigational antiviral remdesivir plus standard care for 5 days (n = 191), 10 days (n = 193) or standard care alone (n = 200). They compared outcomes between each treatment group at day 11.

Researchers found that compared with those who received standard care, patients in the 5-day remdesivir group were 65% more likely to show clinical improvement at day 11 (OR = 1.65; 95% CI, 1.09-2.48).

They also determined that patients in the 10-day remdesivir treatment group had increased odds of clinical improvement at day 11 compared with those who received usual care, but the observed increase was not statistically significant (OR = 1.31; 95% CI, 0.88-1.95).

Marty and colleagues did not identify new adverse events associated with remdesivir in either treatment group. They reported that remdesivir was well-tolerated among the treatment groups, and nausea, diarrhea and headache were the most common adverse events among patients.

According to the press release, Gilead plans to submit the data for publishing in a peer-reviewed journal within the next few weeks.

Merdad Parsey, MD, PhD, chief medical ocer of Gilead Sciences, said in a press release that the new data from the trial “will further guide our research eorts, 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.”

Reuters reported that Gilead confirmed the “alternate formulations” it is developing include an inhaled formulation of remdesivir, which is typically administered intravenously.

References:

Gilead. Gilead announces results from phase 3 trial of remdesivir in patients with moderate COVID-19. 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 2, 2020.

Reuters. Gilead's next step on coronavirus: Inhaled remdesivir, other easier-to-use versions. https://www.reuters.com/article/us-health-coronavirus-gilead-sciences/gileads-next-step-on-coronavirus-inhaled-remdesivir-other-easier-to-use-versions-idUSKBN2391FP. Accessed June 2, 2020.