Gilead Sciences (NSDQ: GILD) announced positive results from a Phase III trial of remdesivir in patients with moderate COVID-19 disease, though the candidate provided only modest improvement. In patients treated with remdesivir for five days, more than half (65%) showed better clinical improvement at Day 11 compared to standard of care (OR 1.65 [95% CI 1.09-2.48]; p=0.017). In the ten day treatment group, remdesivir's benefit did not reach statistical significance. Patient improvement was measured on a seven-point clinical outcome score. Remdesivir is being administered in the US to treat severe COVID-19 disease under Emergency Use Authorization.

In the test, 600 hospitalized patients in the US and EU with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized (1:1:1) to receive open-label remdesivir for 5 or 10 days or standard of care alone. The primary endpoint -- the 7-point ordinal score at Day 11 -- ranged from hospital discharge to increasing levels of oxygen and ventilator support to death. A secondary objective was the rate of adverse events in each remdesivir treatment group compared with standard of care.

“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, and associate professor of medicine at Harvard Medical School. “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.”

“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, Gilead Sciences. “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.”

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