The Feinstein Institutes for Medical Research at Northwell Health and Cold Spring Harbor Laboratory are recruiting COVID-positive adult patients for a fully virtual, in-home clinical trial to evaluate the safety and efficacy of Pepcid (famotidine) for the outpatient treatment of COVID-19. TrialSite supports ongoing important research targeting COIVD-19 hence publishes the need for ongoing participants in this clinical trial in the New York area.
The trial is recruiting patients across the greater New York area who have tested positive for COVID-19, but are experiencing only mild to moderate symptoms that do not require hospitalization.
Sold over-the-counter as Pepcid, famotidine is a histamine 2 blocker used to decrease stomach acid and this clinical trial will assess its use as a COVID-19 therapy.
Patients who qualify will be trained to use a cellular activated Apple iPad from their home, along with a Bluetooth enabled scale, thermometer, fitness tracker, spirometer (to study air flow in and out of the lungs), thermometer and pulse oximeter (to measure blood oxygen levels). Placebo or famotidine at 240 mg per day will be prescribed, and taken orally, for a maximum of 14 days.
Northwell’s Home Lab program will be utilized for required blood draws and COVID-19 diagnostic nasal swabs tests. This trial is designed to keep participants completely out of the hospital throughout the course of their treatment.
This is the first time an entirely virtual clinical trial has been initiated by Cold Spring Harbor Lab and Northwell Health, New York’s largest health system, which has treated more than 100,000 COVID-19 patients since the start of the pandemic in March 2020.
“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,” said Tobias Janowitz, MD, PhD, a medical oncologist, principal investigator of the trial, assistant professor at CSHL, and adjunct professor at the Feinstein Institutes.
“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 said.
Famotidine is a common, safe over-the-counter drug used to treat heartburn and assist with healing gastrointestinal ulcers. In April 2020, the Feinstein Institutes started the nation’s first famotidine clinical trial, which enrolled more than 230 patients. The initiation of the clinical trial was based on anecdotal reports from China that patients taking the drug had better outcomes from COVID-19.
About the Feinstein Institutes
The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest healthcare provider and private employer in New York State. It is home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff in its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine.
Cold Spring Harbor Laboratory, founded in 1890, has shaped contemporary biomedical research and education with programs in cancer, neuroscience, plant biology and quantitative biology. Home to eight Nobel Prize winners, the private, not-for-profit laboratory employs 1,100 people including 600 scientists, students and technicians.
The outpatient famotidine trial has been funded by the Fast Grant and Pershing Square Foundation.