Houston Methodist Enrolling Patients in Two Phase 3 Clinical Studies of Safety and Antiviral Efficacy of Remdesivir to Treat COVID-19
Thursday, March 26, 2020- Houston Methodist Hospital is a participating site for two phase 3 clinical studies to evaluate the safety and efficacy of the Gilead Sciences pharmaceutical Remdesivir in adults diagnosed with coronavirus disease 2019 (COVID-19). Houston Methodist’s participation follows the U.S. Food and Drug Administration’s rapid review and acceptance of Gilead Sciences’ investigational new drug (IND) filing. Remdesivir is an investigational therapy and its safety and efficacy are unknown, necessitating these clinical studies.
Before these two expanded use studies began, Christopher Cortes, MD, medical director of the Medical Intensivist Care Unit, Houston Methodist Critical Care Medicine, enrolled several patients through an FDA-approved Emergency Investigational New Drug (EIND) trial of Remdesivir. A physician may decide to request use of an investigational antiviral product through a single-patient EIND application if the physician considers the product to be urgently needed for a patient in serious condition, if no satisfactory alternative therapy is available, and if the patient cannot receive the product through an existing clinical trial or expanded access protocol.
The two phase 3 clinical studies are randomized, open-label, multi-center studies and began enrolling patients with moderate to severe symptoms on March 23. Kevin A. Grimes, MD, principal investigator, infectious diseases physician, and assistant professor of clinical medicine, and Katherine K. Perez, PharmD, an infectious diseases pharmacist and assistant professor of allied health sciences, are leading efforts for both studies.
One study will evaluate the safety and efficacy of both a 5-day and a 10-day dosing duration of Remdesivir, in addition to the 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 the standard of care for patients with moderate manifestations of COVID-19, compared with the standard of care alone. There are three treatment groups in total between the two studies.