As the coronavirus continues to spread across the world, local hospitals on Long Island are stepping up to the plate to stop the virus in its tracks.
The Feinstein Institutes for Medical Research, which is the research arm of Northwell Health in Manhasset, recently announced the enrollment of three clinical trials in the ongoing effort to combat the coronavirus.
Feinstein Institutes researchers are teaming up with Gilead Sciences, Regeneron Pharmaceuticals and Sanofi to identify effective treatments for patients who are currently hospitalized with moderate and severe conditions of coronavirus. However, the trials are only offered to patients already admitted to Northwell Health hospitals with moderate to severe cases of coronavirus and is not currently available to the 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,” Michael Dowling, president and CEO of Northwell Health, said.
The Feinstein Institutes in partnership with Gilead Sciences will conduct two trials looking at the safety and efficacy of remdesivir (RDV), which is an investigational antiviral drug that is designed to reduce the intensity and duration of the coronavirus 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 coronavirus worldwide 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 the study is Dr. Marcia Epstein, who is a 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 coronavirus cases worldwide. Researchers will look at clinical endpoints and time to discharge. The lead investigator on this study is Dr. Prashant Malhotra, who is an assistant professor in the Institute of Health Innovations & Outcomes Research at Feinstein, and an infectious disease expert.
In collaboration with Regeneron Pharmaceuticals and Sanofi, the Feinstein Institutes will conduct an adaptive randomized trial for approximately 400 severe or critical patients being hospitalized for the virus in multiple sites across the country. It will look at the safety and efficacy of sarilumab, a human antibody that may prevent the activity of a specific cytokine called interleukin-6 (IL-6) that is thought to be important in the development of complications of severe pneumonia in some coronavirus patients.
The role of IL-6 is supported by preliminary data from a Chinese trial and based on those results, which showed rapid reductions in fever in all patients. China recently updated its coronavirus treatment guidelines and approved the use of the IL-6 inhibitor to treat patients with severe or critical disease. The study that the Feinstein Institutes will participate in is the first controlled trial in the U.S. to evaluate the effect of IL-6 inhibition prospectively in coronavirus patients. The lead investigator on this study is Dr. Negin Hajizadeh, who is an assistant professor in the Institute of Health Innovations & Outcomes Research at Feinstein, and a pulmonary and critical care physician.
“As history has shown from past pandemics, medical research will lead in our nation’s ability to reverse the fatal spread of viruses,” Kevin J. Tracey, president and CEO of the Feinstein Institutes, said. “By teaming up with these outstanding pharmaceutical leaders, our researchers have the opportunity to help beat the coronavirus by delivering cutting-edge care through clinical research at our Northwell Health hospitals.”
NYU Winthrop Hospital is operating at 511 beds currently, which the hospital is looking to expand, due to Governor Andrew Cuomo’s request that hospitals increase their capacity by 50 percent.
“We’ve identified spaces so that we can increase bed capacity by 50 percent, including in surgical units where we previously performed elective surgeries,” Dr. Joseph Greco, senior vice president and Chief of Hospital Operations at NYU Winthrop Hospital said. “We’ll increase bed capacity in stages as needed. Right now we’re putting the finishing touches on a unit in what used to be conference space, and we expect that to be ready for patients on Friday [March 27].”
Additional beds will soon follow in other space being converted and sections of the hospital cafeteria may be next.
“We’re also establishing an emergency department triage tent near to our ER entrance to improve management of those with respiratory symptoms,” a hospital spokesperson added.
Last week, Mt. Sinai South Nassau Hospital in Oceanside also opened a coronavirus triage tent outside its premises. People who come to the hospital with sub-acute coronavirus-like symptoms will be directed to the triage tent instead of the emergency room.