Hospitalized COVID-19 patients who received a common heartburn drug, famotidine, were twice as likely to survive, according to a new observational study conducted at Columbia University Irving Medical Center.
“Our finding is compelling, considering the poor clinical outcomes associated with severe COVID-19, but it would be premature to conclude that famotidine has a protective effect,” says the study’s leader Daniel Freedberg, MD, MS, assistant professor of medicine and epidemiology at Columbia University Vagelos College of Physicians and Surgeons.
“We found an association between famotidine and improved outcomes in our analysis, but there could be unknown factors that we were unable to account for that might explain this finding,” Freedberg adds. “Whether famotidine is effective as a treatment for patients with COVID-19 is an open question and needs to be explored in a randomized clinical trial.”
The study was published online in the journal Gastroenterology in May.
Why study famotidine?
Famotidine, which reduces stomach acid, is commonly used to treat occasional episodes of heartburn (when stomach acid backs up into the esophagus) and gastroesophageal reflux disease (persistent heartburn).
The study at Columbia University Irving Medical Center was motivated by prior investigations of famotidine for treating COVID-19. Unpublished data from Wuhan, China, found better outcomes in COVID-19 patients who took famotidine while hospitalized. And a computational chemistry study of famotidine suggested that the drug might bind to part of the virus and prevent it from reproducing inside cells.
“These reports prompted us to look at our own institution’s data to see if there was any association between famotidine use and outcomes in hospitalized COVID-19 patients,” says senior author Julian Abrams, MD, MS, associate professor of medicine and epidemiology at Columbia University Vagelos College of Physicians and Surgeons.
What the study did
The study looked at the health records of 1,620 adults hospitalized with COVID-19 who did not require intensive care at the time of admission. About 5% (84) received famotidine with 24 hours of hospitalization, including patients who had been taking the drug at home.
“In most cases, the reason why famotidine was prescribed in the hospital was not documented in the medical records,” Abrams says, “but we suspect that the drug was most likely prescribed for the treatment of acid reflux.”
What the study found
The researchers found a 2-fold reduction in intubation or death among patients taking famotidine compared to those who did receive not the drug.
The researchers found that 10% of patients who received famotidine were placed on a ventilator or died, compared to 22% of patients who didn’t receive famotidine. This association persisted even after accounting for a variety of factors that could be associated with worse outcomes in these patients.
The study also looked at patients who were given proton pump inhibitors, a different type of drug that also reduces stomach acid. The researchers found that these drugs were not associated with improved outcomes, suggesting that any effect of famotidine on COVID-19 outcomes is not related to the suppression of stomach acid.
The current study shows that famotidine is associated with better outcomes, but only randomized, controlled clinical trials can determine if famotidine is truly effective.
“We don’t know if there is any benefit of taking famotidine if you have COVID-19, and we strongly recommend consulting with your physician before doing so,” Freedberg says. “Though famotidine is generally considered very safe, no medication—prescribed or over-the-counter—is without potential downsides.”
Clinical trials needed
Columbia University Irving Medical Center is now participating in a randomized, controlled clinical trial of famotidine in patients hospitalized with COVID-19. The trial is comparing the use of famotidine vs. placebo. (Hydroxychloroquine also was originally given to patients in both arms, but this aspect has recently been removed from the trial.) Northwell Health is the primary site for the clinical trial, which is led by Joseph Conigliaro; Daniel Freedberg is principal investigator of the trial at CUIMC.
“If famotidine is found to have a protective effect, additional studies are warranted to determine if starting even earlier—at the onset of symptoms—can decrease the risk of subsequent hospitalization,” Abrams says. “For any intervention aimed at improving COVID-19 outcomes, timing is likely to be critical.”