Enrollment Begins in NIH-Sponsored Trial of Remdesivir for COVID-19 Patients
Institutions also announce enrollment in study evaluating efficacy of sarilumab for hospitalized COVID-19 patients
FRIDAY, April 3, 2020 (HealthDay News) -- A number of institutions this week announced their participation in an international clinical drug trial evaluating the safety and efficacy of remdesivir in hospitalized patients with the novel coronavirus 2019 (COVID-19).
Northwestern Medicine, Cedars-Sinai, UC Davis, and the University of Illinois at Chicago are among the institutions announcing patient enrollment in the randomized, placebo-controlled, double-blind trial, sponsored by the National Institute of Allergy and Infectious Diseases/Division of Microbiology and Infectious Diseases of the National Institutes of Health. The trial will be conducted at around 50 sites and will enroll up to 440 patients. The novel antiviral drug, remdesivir, was developed to treat Ebola, and animal study data have shown the drug has antiviral activity against coronaviruses including Middle East Respiratory Syndrome and severe acute respiratory syndrome coronavirus 2.
Trial participants will receive placebo or 200 mg remdesivir intravenously on the first day, followed by a 100-mg maintenance dose once a day until the patient recovers or for a maximum of 10 days. Patients will be evaluated for 30 days. In four studies of remdesivir in Ebola trials in Africa, researchers found the drug led to elevated liver function tests, while others had abnormal blood clotting tests and gastrointestinal side effects. Patients' liver function will be carefully monitored in the current trial.
UC Davis, Roswell Park Comprehensive Cancer Center and the University of Buffalo, and the University of Illinois at Chicago also announced participation in an adaptive phase 2/phase 3 study of sarilumab, which is approved for the treatment of rheumatoid arthritis. This study is sponsored by Regeneron Pharmaceuticals in a public-private partnership with the U.S. Department of Health and Human Services, the U.S. Office of the Assistant Secretary for Preparedness and Response, and the U.S. Biomedical Advanced Research and Development Authority. Hospitalized patients with COVID-19 who enroll in the study will be randomly assigned to sarilumab 200 mg, sarilumab 400 mg, or placebo delivered in a single intravenous infusion.