Famotidine Trial Underway in NYC for COVID-19 Treatment

April 27, 2020

Famotidine, the active compound in an OTC heartburn drug, may disable a key enzyme that COVID-19 uses to replicate.

Famotidine, the active compound in the OTC heartburn drug Pepcid, is being tested to treat patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), by Northwell Health in the New York City area, Science Magazine reported.1

The randomized, double-blind trial, which began on April 7, has enrolled 187 participants to date, but expects to expand to a total of 1174 individuals in critical status, including many on ventilators, due to the virus.1

The potential for intravenous famotidine treatment for the novel coronavirus has been kept under wraps in order for the hospital system to be able to maintain a sufficient stockpile of the drug. Treatment dosage using famotidine is 9 times higher than its dosage for heartburn and researchers were concerned that failing to keep quiet would cause consequences similar to that of hydroxychloroquine supplies, which are currently in shortage.1,2 “If we talked about this to the wrong people or too soon, the drug supply would be gone,” said Kevin Tracey, MD, president and CEO of the Feinstein Institute for Medical Research and the director of the Laboratory of Biomedical Science, who is leading the study.

Related: Coronavirus News Roundup: Drug Shortages, Clinical Trials, Testing Resources for Pharmacies

Global confirmed cases have risen to 3,002,303 at the time of this article’s publication, and the United States accounts for 972,969 of those cases.3

The 23-hospital system is also testing Regeneron’s sarilumab and Gilead Sciences’ remdesivir for treatment of COVID-19.1

Famotidine’s potential use for COVID-19 was first demonstrated in China; Michael Callahan, MD, traveling infectious disease doctor based at Massachusetts General Hospital, noticed and brought the news to Tracey in the United States, according to Science Magazine.1

The prospective use of famotidine for severe symptoms of COVID-19 stemmed from observations in Wuhan that showed an unexpected pattern: many elderly survivors of COVID-19 tended to be poor.1

Investigators examined 6212 COVID-19 patient records and found that those patients had a common secondary condition–heartburn. Economically disadvantaged survivors had been taking the less expensive famotidine rather than omeprazole (Prilosec). Hospitalized patients on famotidine were dying at a 14% rate compared with 27% for those not on the drug. Although the results were not statistically significant, it caught the interest of scientists in the United States.1

Tracey and Northwell Health have not only kept the drug trial quiet, but also has remained restrained in promoting early enthusiasm, especially following President Trump’s premature enthusiasm of unproven hydroxychloroquine.1 “If it does work, we’ll know in a few weeks,” he said.

References:

1. Borrell B. New York clinical trial quietly tests heartburn remedy against coronavirus. Science. April 26, 2020. doi:10.1126/science.abc4739
2. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydroxychloroquine%20Sulfate%20Tablets&st=c. Accessed April 27, 2020.
3. Coronavirus Resource Center. Johns Hopkins University and Medicine. https://coronavirus.jhu.edu/map.html. Accessed April 27, 2020.