Gilead Initiates Two Global Phase 3 Clinical Trials of Remdesivir for COVID-19 Treatment

February 26, 2020 (Pacific Time) – Foster City, California – Gilead Sciences announced the initiation of two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adult patients with coronavirus disease 2019 (COVID-19). Beginning in March, these randomized, open-label, multicenter studies will be conducted primarily at medical centers in Asia and other countries with a high number of confirmed cases globally, enrolling approximately 1,000 patients. The studies will assess two intravenous dosing regimens of remdesivir. Gilead submitted Investigational New Drug (IND) applications for the use of remdesivir in the treatment of COVID-19, and the U.S. Food and Drug Administration (FDA), following an expedited review, approved Gilead to commence these clinical trials.

New clinical studies have expanded the ongoing research on remdesivir, including two clinical trials conducted in Hubei Province, China, under the auspices of China-Japan Friendship Hospital, as well as a recent clinical trial led by the National Institute of Allergy and Infectious Diseases (NIAID) in the United States. Gilead Sciences donated the drug and provided scientific support for these studies, with results from the Chinese clinical trials expected in April.

Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences, stated:“Gilead’s primary focus is to rapidly determine the safety and efficacy of remdesivir as a potential treatment for novel coronavirus disease (COVID-19). These complementary studies help us obtain broader global data on this drug within a short timeframe. The rapid initiation of research on remdesivir for coronaviruses reflects the urgency in seeking therapeutic solutions and the strong sense of mission shared by the pharmaceutical industry, governments, global health organizations, and healthcare professionals in jointly addressing this public health challenge.”

Gilead-Initiated Clinical Trials to Evaluate Two Remdesivir Dosing RegimensThe clinical trials initiated by Gilead Sciences will evaluate two dosing regimens of remdesivir. One study will enroll approximately 400 patients with severe manifestations of novel coronavirus pneumonia (COVID-19), who will be randomly assigned to receive either a 5-day or a 10-day course of remdesivir treatment. The second study will involve approximately 600 patients with moderate clinical symptoms, who will be randomly assigned to receive either a 5-day or a 10-day course of remdesivir treatment, or standard care alone. The primary endpoint for both studies is improvement in clinical symptoms; detailed descriptions are provided at the end of this document.

Remdesivir has not yet been licensed or approved in any country worldwide, and its safety and efficacy have not been established. In addition to ongoing clinical trials, Gilead Sciences is collaborating with government agencies, non-governmental organizations, and local regulatory authorities to provide emergency compassionate-use treatment for eligible patients with novel coronavirus pneumonia (COVID-19).

For more responses from Gilead Sciences regarding the novel coronavirus outbreak, please visit the company’s website or follow Gilead China’s official WeChat posts.

AboutRemdesivir

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity. It has demonstrated activity against multiple emerging viral pathogens, including Ebola virus, Marburg virus, Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome (SARS) viruses, in both in vitro studies and in vivo animal models. Studies on remdesivir have been conducted in healthy volunteers and patients infected with the Ebola virus. Individual compassionate-use cases are insufficient to determine the safety and efficacy of remdesivir for the treatment of novel coronavirus pneumonia (COVID-19), which can only be established through future clinical trials.

AboutNew Remdesivir Clinical Trial Initiated by Gilead Sciences

The first of the two studies will evaluate the safety and efficacy of remdesivir using 5-day and 10-day intravenous administration regimens. Approximately 400 patients with severe symptoms will be randomized in a 1:1 ratio to receive, in addition to standard care, an initial intravenous dose of 200 mg remdesivir on Day 1, followed by 100 mg daily until either Day 5 or Day 10. The primary objective of this study is to assess the efficacy of remdesivir by measuring the normalization of body temperature and oxygen saturation (defined as axillary temperature <36.6°C, oral temperature <37.2°C, or rectal temperature <37.8°C; and oxygen saturation >94%, sustained for at least 24 hours through Day 14).

The second study will evaluate the safety and efficacy of 5-day and 10-day intravenous remdesivir regimens in patients with moderate symptoms of novel coronavirus pneumonia (COVID-19), compared with those receiving standard care alone. Approximately 600 participants will be randomized in a 1:1:1 ratio. In addition to standard care, patients will receive an initial dose of 200 mg of remdesivir on day 1, followed by daily doses of 100 mg through either day 5 or day 10, and their outcomes will be compared with those of participants receiving standard care alone. The primary objective of this study is to assess the efficacy of remdesivir by measuring the proportion of patients discharged from the hospital by day 14 in each group.

AboutGilead Sciences

Gilead Sciences is a research-based biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies in areas of unmet medical need. The company’s mission is to transform and simplify treatment regimens for patients with serious diseases worldwide. Gilead operates in more than 35 countries around the world, with its headquarters located in Foster City, California.

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