Virtual Clinical Trial Kicks Off in NY to Study COVID-19 Therapy

The Feinstein Institutes for Medical Research, part of Northwell Health, and Cold Spring Harbor Laboratory (CSHL) recently launched a fully virtual clinical trial to evaluate the safety and efficacy of a COVID-19 therapy in adults.

The randomized, double-blind trial will evaluate famotidine, or PEPCID, an over-the-counter histamine 2 blocker used to decrease stomach acid, in adult patients in the greater New York area who are infected with mild to moderate COVID-19. 

Northwell Health is New York’s largest health system, treating over 100,000 patients since the start of the pandemic. This trial is the first entirely virtual clinical trial initiated by CSHL and Northwell Health.

“From the comfort of these patients’ own homes, we are taking the traditional clinical trial completely digital to study the efficacy and safety of a potential COVID-19 therapy,” Tobias Janowitz, MD, PhD, a medical oncologist and assistant professor at CSHL, and principal investigator of the trial, said in the announcement. 

“From assessment, to enrollment and daily data collection, we hope this study’s model will be an example for future clinical trials, and will provide high quality data as we assess candidate treatments, like famotidine, to curb this disease,” Janowitz continued. 

In the trial, patients will be trained to use an Apple iPad from their home, along with a Bluetooth-enabled scale, thermometer, fitness tracker, spirometer, thermometer, and pulse oximeter, a Northwell Health spokesperson said. 

Patients in the trial will receive 250 milligrams of Famotidine or a placebo per day for a total of 14 days. Northwell Health’s Home Lab program will be used for blood draws and COVID-19 diagnostic nasal swab tests.

Notably, the goal of the trial is to keep patients out of the hospital throughout the course of treatment. 

At the start of the pandemic, the Feinstein Institutes established a COVID-19 Clinical Trial Unit (CCTU), a 200-member rapid-response clinical trial group of scientists, physicians, administrators, and staff to review and launch clinical trials.

So far, CCTU has enrolled nearly 1,200 patients in over seven clinical trials and programs studying famotidine, remdesivir, sarilumab, and convalescent plasma. 

“It’s been more than a year since this pandemic has spread across the globe, and there is only one fully-authorized COVID-19 therapeutic,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes. 

“This innovative clinical trial of patients in their own homes should provide important data to determine if a safe and inexpensive drug may be useful for COVID-19 patients,” Tracey continued. 

In April 2020, the Feinstein Institutes started the nation’s first famotidine clinical trial, which enrolled over 230 patients. The trial was launched based on data from China that said patients taking the drug had better outcomes when infected with COVID-19. 

The coronavirus pandemic has significantly increased the use of virtual care and telehealth, helping both patients and care providers by minimizing transmission risk of SARS-CoV-2, while also delivering specialty care to patients in need.

A November 2020 survey of nearly 1,600 healthcare providers found that about 70 percent are motivated to use more telehealth because of the experiences they’ve had during COVID-19 and 

more than half said their overall outlook has changed because of connected health. 

Over three-quarters of providers said that telehealth helped them to provide quality of care for their patients, 80 percent said that telemedicine platforms and mHealth tools enhanced the timeliness of patient care, and 60 percent stated that telehealth improved their patient’s overall health.

Overall, virtual clinical trials can improve the comfort, convenience, and confidentiality for participants compared to a traditional site-based clinical trial, ensuring more overall patient engagement. 

Additionally, virtual trials enhance the quality of endpoints and outcome measurements in a way that allows questions about a patient's quality of life to be better addressed.