One of the hardest lessons Feinstein Institutes for Medical Research CEO Kevin Tracey, MD, learned in 2020 was how difficult conducting successful clinical trials during a pandemic is.
"The last thing any patient wants to do is make special trips to any doctor's office or any hospital because they're in a clinical trial," he said.
The physician and his team were among the first in the U.S. to stand up trials for COVID-19 treatments. As the COVID-19 Clinical Trials Unit of New Hyde Park, N.Y.-based Northwell Health, they managed to get seven trials off the ground and enroll 1,300 patients.
"I felt like I was on a team that had been training for their whole life for a specific event, and when the time came to do their part in this event, everyone did it."
Over the course of the pandemic, Dr. Tracey realized the value a virtual trial would bring to the table. With Christina Brennan, MD, the Feinstein Institutes' vice president of research, Dr. Tracey launched Northwell Health's first at-home trial. At its center was famotidine, a heartburn drug some studies suggest could protect from serious complications and death in COVID-19 patients.
The study, which is still in progress, is designed to keep patients entirely out of the hospital during treatment. Participants, who have all been diagnosed with mild to moderate cases, receive tools including an iPad, spirometer and 240 milligrams of famotidine or placebo to be taken for 14 days. Lab and blood work is completed at home.
Dr. Tracey is looking forward to using the virtual approach in future trials; cancer trials in particular.
"We have learned a huge amount about how to do clinical trials in an impactful way," he said. "That kind of learning will continue to improve our research enterprise at Northwell for years to come."