Northwell Health launches clinical trials for Covid-19 patients

For hundreds of patients hospitalized with Covid-19, there is new hope for treatment.

The Feinstein Institutes for Medical Research, Northwell Health‘s research arm, is starting to enroll moderately and severely ill patients in a trio of clinical trials. The trials are designed to provide participating patients access to treatments that could aid in and hasten their recovery. They’ll also help to determine the safety and efficacy of such treatments through the regulatory approval process.

Feinstein is working with Regeneron Pharmaceuticals of Westchester County and French biopharmaceutical firm Sanofi on a trial for a human antibody that might help ward off complications of severe pneumonia in Covid-19 patients. The trial can enroll up to 400 severe or critical patients in multiple sites across the United States.

Northwell, which signed on as the first site, has so far enrolled 10 patients in the trial, said Dr. Christina Brennan, vice president of clinical research at the Feinstein Institutes. About 250 Covid-19 patients are currently hospitalized at Northwell facilities.

Beyond the Regeneron collaboration, the Feinstein Institutes will conduct two trials for an investigational antiviral drug designed to reduce the intensity and duration of Covid-19 with Gilead, a biotechnology company in Foster City, Calif. The drug has been shown to have positive effects on other viral pathogens, such as MERS and SARS, in the lab and in animal models.

The trials can accommodate thousands of severe and moderate Covid-19 cases globally.

“There’s no approved drug for Covid-19, so to have the opportunity to have a drug available for [patients] prior to it being commercially approved is an incredible opportunity we can bring to our patients that offers hope that the drug will work,” Brennan said.
Many institutions have been requesting drugs not yet approved to treat Covid-19 through the U.S. Food and Drug Administration’s compassionate-use path. But launching clinical trials will enable Northwell to have quantities of the drugs readily available.
Northwell is putting all its clinical-trial efforts into potential treatments for Covid-19.
Elsewhere in New York, Mount Sinai and New York–Presbyterian are slated to participate in the Regeneron trial. Many institutions locally—and globally—are clamoring to be part of Gilead’s trial.

Brennan said she didn’t know how long it would take for such drugs to be commercially available but said she believes the FDA is working on an expedited time frame. Results of the trials will not be available until 60 days after the last enrolled participant is first dosed.

https://www.crainsnewyork.com/coronavirus/northwell-health-launches-clinical-trials-covid-19-patients