Gilead Reports Remdesivir Helped Moderately Ill COVID-19 Patients

Gilead Sciences recently announced positive results from its Phase 3 SIMPLE clinical trial evaluating remdesivir as a COVID-19 drug for moderately ill COVID-19 patients.

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The randomized study included hospitalized patients with confirmed COVID-19 pneumonia without reduced oxygen levels received open-label remdesivir for five or ten days or standard of care alone. 

Researchers found that patients in the five-day remdesivir treatment group were 65 percent more likely to see clinical improvement at day 11 versus individuals receiving standard care. 

Although those in the ten-day treatment group saw positive results, they did not reach statistical significance.

“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 associate professor of medicine at Harvard Medical School, said in the announcement. 

“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.”

At the beginning of May, FDA granted emergency use authorization (EUA) to Gilead for remdesivir to treat patients infected with the virus. 

The EUA allowed for remdesivir to be distributed in the US and administered intravenously by healthcare providers, as appropriate, to treat COVID-19 in adults and children hospitalized with severe disease.

In mid-April, a study analyzed the effects of remdesivir provided to patients who had an oxygen saturation or 94 percent or less while breathing ambient air or who were receiving oxygen support from January 25, 2020, through March 7, 2020. After 18 days, 36 patients (68 percent) of the 53 patients had an improvement in oxygen-support class. These results included 17 of the 30 patients (57 percent) receiving mechanical ventilation who were extubated.

The study also showed that 25 patients were discharged, while seven patients died. Mortality was 18 percent among patients receiving invasive ventilation and five percent among those not receiving invasive ventilation. 

A 28-day follow up showed that the cumulative incidence of clinical improvement, as defined by either a decrease of two points or more on the six-point ordinal scale.  About 84 percent of COVID-19 patients fell into this category. But clinical improvement was not as frequent among patients receiving invasive ventilation than among those receiving noninvasive ventilation for improvement. 

The Phase 3 SIMPLE study’s primary endpoint was the clinical improvement by day 11, ranging from hospital discharge to increasing levels of oxygen and ventilator support to death, researchers said.

Remdesivir was generally tolerated in both the five-day and ten-day treatment groups, Gilead said. 

The most common adverse events occurring in more than five percent of patients in both treatment groups were nausea, diarrhea, and headache. Additionally, non-statistically significant increases in clinical worsening or death were observed in the standard of care group compared to the remdesivir group.

“We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results,” said Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences. 

“The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes. Our SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course.”

Parsey also noted that the additional data will further guide research efforts, such as evaluating treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, and pediatric studies and the development of alternate formulations.