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Feinstein Institutes Begins Enrolling Patients in Multiple COVID-19 Clinical Trials

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Summation

  • 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 COVID-19 patients.

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 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, 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 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 the current standard of care in up to 600 patients with moderate COVID-19 globally. 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.

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 US. 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 COVID-19 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 COVID-19 treatment guidelines and approved the use of that 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 COVID-19 patients. The lead investigator on this study is Negin Hajizadeh, MD, 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,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes. “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.”

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