Northwell Health’s Feinstein Institutes for Medical Research has partnered with Gilead Sciences, as well as Regeneron and Sanofi, and has commenced treating patients as part of three clinical trials involving hospitalized COVID-19 patients. Demonstrating urgent agility, New York State’s largest health care provider and its research division is taking action now. Medical research will lead the way to reverse the fatal spread of this virus.
By mobilizing its Feinstein Institutes for Medical Research, the prominent health care provider has measured up the severity of the crisis and the associated risks and has decided to move forward—full throttle. Given Northwell’s position as the state’s largest health care provider, they have considerable credibility in assessing the current situation and the projected growth in hospitalizations due to the pandemic.
Full Throttle Patient Enrollment Commences
The research arm (Feinstein Institutes of Medical Research) and the provider (Northwell Health) understands the unprecedented nature of this pandemic and are reacting accordingly. With an emphasis first and foremost on patient safety, Northwell Health President and CEO Michael Dowling noted: “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.”
Participation in Three Clinical Trials
The Feinstein Institutes for Medical Research announced the enrollment of three clinical trials in the ongoing effort to combat COVID-19—the novel coronavirus, as reported in an internally-originated press release. The prominent research site reports that they have teamed with Gilead Sciences, Regeneron, and Sanofi to identify effective treatments for patients currently hospitalized in moderate and severe conditions with COVID-19. The goal is nothing other than A) improve patient recovery, and B) speed discharge from hospitals.
Patients that have been admitted to Northwell Health hospitals and meet other inclusion criteria will have access to these clinical trials. These clinical trials are not available to the general public.
The Feinstein Institute Trials
The Feinstein Institute of Northwell Health will conduct three clinical trials with hospitalized patients. The first two studies involve the drug TrialSite News had written about—Gilead’s remdesivir, originally developed for Ebola, originates from a collaboration from the University of Alabama. The first remdesivir study assesses the safety and efficacy of remdesivir. This drug has evidenced some positive effects on other viruses, such as MERS and SARS in vitro and animal models. Led by principal investigator Marcia Epstein, the Feinstein Institutes study team will assess clinically relevant endpoints in patients with severe symptoms.
The second study, a phase III clinical trial, tests a couple of remdesivir treatment durations and compares to the standard of care in up to 60 patients afflicted with moderate COVID-19 worldwide. The principal investigator is Prashant Malhotra, MD, assistant professor at the Institute of Health Innovations & Outcomes Research at Feinstein Institute for Medical Research who also serves as an infectious disease expert.
The third trial centers on the Regeneron Pharmaceuticals collaboration with Sanofi. The Feinstein Institute of Medical Research will participate as a site to help treat severe or critical patients hospitalized due to the virus. The study tests the safety and efficacy of the human antibody sarilumab (Kevzara®).
The sponsors and investigators have evidence that it can prevent the activity of a specific cytokine known as interleukin-6 (IL-6), which is believed to contribute to complications of severe pneumonia in at least some novel coronavirus patients. This study represents the first in America, where the effects of IL-6 inhibition prospectively in SARS-CoV-2 patients will be assessed. Negin Hajizadeh, MD, assistant profession in the Institute of Health Innovations & Outcomes Research at Feinstein and a pulmonary and critical care physician, serves as principal investigator.
The Feinstein Institutes for Medical Research
The research arm of New York State’s largest health care provider, Northwell Health, the Feinstein Institutes for Medical Research is home to 50 research labs, 2,500 clinical research studies, and 4,000 professionals and staff. An elite research institution, investigators here have made breakthroughs in molecular medicine, genetics, cancer, brain research, mental health, autoimmunity, and bioelectronic medicine, among others. It is the laboratory and faculty home of the Elmezzi Graduate School of Molecular Medicine.
Marcia Epstein, MD, Infectious Disease, Internal Medicine
Prashant Malhotra, MD, assistant professor at the Institute of Health Innovations & Outcomes Research at Feinstein Institute for Medical Research
Negin Hajizadeh, MD, assistant profession in the Institute of Health Innovations & Outcomes Research at Feinstein and a pulmonary and critical care physician
Call to Action: TrialSite News will monitor these studies closely. Sign up for our newsletter for updates.