LI Volunteers Sought For Virtual Coronavirus Clinical Trial

MANHASSET, NY — Patients are being sought to volunteer for a clinical trial to evaluate the safety and efficacy of a potential outpatient treatment for the coronavirus, The Feinstein Institutes for Medical Research and Cold Spring Harbor Laboratory announced.

The virtual, in-home, double-blind and placebo-controlled clinical trial would evaluate the ability of famotidine, or PEPCID, to treat mild to moderate COVID-19 in adults. Famotidine, sold over the counter as PEPCID, is used to decrease stomach acid. The trial would check its use as a COVID-19 therapy.

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.

This marks the first time an all-virtual clinical trial has been launched by Cold Spring Harbor Laboratory and Northwell Health; the latter of which has treated more than 100,000 COVID-19 patients since the pandemic began, according to the release.

Patients who qualify and consent will be trained to use a cellular activated Apple iPad from their home; along with a Bluetooth-enabled scale; thermometer; fitness tracker; spirometer to track airflow in and out of lungs; and pulse oximeter to measure blood oxygen levels. The placebo or famotidine at 240 mg per day will be prescribed, which patients will take orally for up to 14 days.

Northwell's Home Lab program will be used for required blood draws and COVID-19 diagnostic nasal swabs tests. The trial is designed to keep participants out of the hospital throughout the course of their treatment.

"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."

For those who want to learn more about the clinical trial, you can email ClinicalTrials@northwell.edu.

Famotidine is a common 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 trial was based on anecdotal reports from China that patients taking the drug dealt with COVID-19 better, according to the news release.

"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."

When the pandemic began, the Feinstein Institutes established its 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. Since March, the CCTU has enrolled patients in more than seven clinical trials and programs — including famotidine, remdesivir, sarilumab and convalescent plasma. More than 1,200 patients were enrolled into COVID-19 research trials across the health system, resulting in more than 200 manuscripts published, providing guidance to clinicians worldwide.

The outpatient famotidine trial has been funded by the Fast Grant and Pershing Square Foundation.