By: Angelo Cordoza
The Feinstein Institutes for Medical Research, the research arm of Northwell Health, said that the enrollment of three clinical trials in the ongoing effort to combat COVID-19, the novel coronavirus.
Feinstein Institutes researchers are teaming up with Gilead Sciences, Regeneron Pharmaceuticals and Sanofi to identify effective treatments for patients currently hospitalized in moderate and severe conditions with COVID-19, the company said in a press statement posted on its web site. The goal is to improve recovery and speed discharge from hospitals. The three Feinstein Institutes trials are offered to patients already admitted to Northwell Health hospitals with moderate to severe COVID-19. The trials are not currently available to the general public.
“We’ve joined with three outstanding companies to immediately begin clinical trials for patients now suffering from COVID-19 and are determined to do all we can to stop the virus in its tracks,” said Michael Dowling, president and CEO of Northwell Health.
While there is a nationwide push for an expedited Food and Drug Administration (FDA) approval process of these and other experimental COVID-19 therapies, the release said, Northwell Health and the Feinstein Institutes prioritize the safety of patients. The process of these formal trials will lead to accurate testing of these novel drugs prior to mainstream use.
With Gilead, the statement continued, the Feinstein Institutes will conduct two trials looking at the safety and efficacy of remdesivir (RDV), an investigational antiviral drug, designed to reduce the intensity and duration of COVID-19 in hospitalized patients. RDV has demonstrated positive effects on other viral pathogens such as MERS and SARS in vitro and in animal models. “The first trial can accommodate up to 400 severe cases of COVID-19 globally and is a randomized study of two different durations of treatment with RDV, delivered intravenously. Researchers will look at clinically relevant endpoints in patients with severe manifestations of disease. The lead investigator on this study is Marcia Epstein, MD, Feinstein Institutes researcher and an infectious disease expert.”
The other RDV trial in collaboration with Gilead is also a phase 3 study that will assess two different durations of treatment with RDV as compared to current standard of care in up to 600 patients with moderate COVID-19 globally, the company pointed out. “Researchers will look at clinical endpoints and time to discharge. The lead investigator on this study is Prashant Malhotra, MD, assistant professor in the Institute of Health Innovations & Outcomes Research at Feinstein, and an infectious disease expert.”