“We intend to get that to patients in the early part of this next week, beginning to work with the government which will determine which cities are most vulnerable and where the patients are that need this medicine,” O’Day said.
Gilead has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing. These randomized, open-label, multicenter studies began enrolling patients in March 2020 and will enroll a total of approximately 1,000 patients in the initial phase of the studies, in countries with a high prevalence of COVID-19.
The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing duration of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone.
Health authorities in China have initiated two clinical trials in patients who have been infected with COVID-19 to determine the safety and efficacy of remdesivir as a potential treatment for the coronavirus. The two studies are being coordinated by the China-Japan Friendship Hospital and are being conducted at multiple sites in Hubei province. Gilead is providing study drug at no charge and provided input on study design and conduct.
One study is evaluating remdesivir in patients with confirmed disease who have developed more severe clinical manifestations such as a requirement for supplemental oxygen. The other study is evaluating remdesivir in patients with confirmed COVID-19 infection who have been hospitalized but are not displaying significant clinical manifestations of disease such as an oxygen requirement.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has initiated a Phase 2 adaptive, randomized, double-blind, placebo-controlled trial into remdesivir as a potential treatment for hospitalized adult patients diagnosed with COVID-19. Gilead is providing study drug at no charge and provided input on study design and conduct.
Additionally, INSERM in France has initiated a study evaluating remdesivir and other potential treatments, using a master protocol developed by WHO. Gilead is providing study drug at no charge and provided input on study design and conduct.
Additional information on the six ongoing remdesivir studies is accessible at the following links:
- Gilead study in patients with moderate disease: NCT04292730
- Gilead study in patients with severe disease: NCT04292899
- NIAID study: NCT04280705
- INSERM study: 2020-000936-23
- China study in patient with mild/moderate disease: NCT04252664
- China study in patients with severe disease: NCT04257656