Gilead Phase III trial of remdesivir for COVID-19 shows 65 percent are 'more likely' to improve by day 11

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Gilead Sciences said on Monday that remdesivir, the experimental drug being tested for COVID-19, showed that 65 percent of moderately ill patients had improvement after 11 days.

The Phase III trial evaluated both five and 10-day courses of treatment and noted that 65 percent of patients in the five-day treatment group had improvement at day 11, compared to those who were given standard care. There were also improvements shown in the 10-day treatment group, but no statistical significance compared to the five-day treatment.

“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Dr. Francisco Marty, an infectious diseases physician at Brigham and Women’s Hospital, in a statement obtained by Fox News. “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.”

Remdesivir antiviral drug with pills and Syringe as background - concept of covd-19 or coronavirus new possible antiviral drug medication (Credit: iStock)

Remdesivir antiviral drug with pills and Syringe as background - concept of covd-19 or coronavirus new possible antiviral drug medication (Credit: iStock) (iStock)

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A separate study from the National Institutes of Health published last week also showed the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received the placebo.

Remdesvir is currently only approved for SARS-CoV-2 in Japan, but the FDA allowed emergency use approval of the experimental drug in early May.

“We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures," said Dr. Merdad Parsey, Ph.D., Chief Medical Officer, Gilead Sciences, in the statement. "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."

Parsey continued: "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. 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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The biotech giant said recently it is working with "leading chemical and pharmaceutical companies" to make sure remdesivir is available in Europe, Asia and the developing world.

The antiviral was previously used to treat Ebola patients and has been garnering massive attention as the world scrambles to contain the coronavirus pandemic. Experts, however, warn that people should not take drugs unless prescribed by a doctor.

Currently, there is no known scientific cure for the disease known as COVID-19, however, a number of drugs are being tested to see if they can treat it.

Shares of Gilead were lower in early Monday trading, down 2.9 percent to $75.59.

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As of Monday morning, more than 6.1 million coronavirus cases have been diagnosed worldwide, more than 1.79 million of which are in the U.S., the most impacted country.

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