Treatment with famotidine resulted in earlier alleviation of symptoms and reduced inflammation in unvaccinated adult outpatients with confirmed SARS-CoV-2 infection, according to findings from a phase 2 clinical trial.

The randomized, double-blind, placebo controlled, fully remote study (ClinicalTrials.gov Identifier: NCT04724720) was led by The Feinstein Institutes for Medical Research at Northwell Health and Cold Spring Harbor Laboratory. Patients with mild to moderate COVID-19 were randomly assigned to receive famotidine 80mg (n=28) or placebo (n=27) orally 3 times daily, which was self-administered for 14 days.

The primary endpoint of the study was the cumulative incidence of symptom resolution at day 28. “Symptom resolution was defined as the first time that the total symptom score was ≤3, and no individual symptom score was >1 for 2 consecutive days,” the investigators explained. The rate of symptom resolution was designated as a secondary endpoint.

The median age of the participants was 35 years; 64% (n=35) were women, 33% (n=18) were African American, and 26% (n=14) were Hispanic. Of the total 55 participants, 95% (n=52) completed the study.

Results showed a statistically significant improvement in the rate of symptom resolution in patients treated with famotidine (P <.0001); however, time to symptom resolution was not significantly different between the famotidine and placebo arms (P =.04).

Overall symptom scores were reduced by an estimated 50% at 8.2 days (95% CI, 7-9.8) for the famotidine group and 11.4 days (95% CI, 10.3-12.6) for the placebo group. Famotidine-treated patients reported earlier improvements in 14 out of 16 assessed symptoms, including breathing, chest congestion, cough, and abdominal pain.

Famotidine treatment was also associated with earlier resolution of inflammation (based on reduced type-I interferon levels). Findings also showed no significant differences between groups with regard to plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein, indicating that the H2-receptor antagonist does not appear to compromise antiviral immunity.

“We found that famotidine is safe at the higher doses used and see molecular and clinical evidence that it improves the recovery of symptomatic patients of diverse ancestries diagnosed with COVID-19,” said Tobias Janowitz, MD, PhD, principal investigator of the trial, assistant professor at CSHL and adjunct professor at the Feinstein Institutes. “We hope that the data we are sharing with this study guide future trials that are necessary to confirm famotidine as a treatment for patients with COVID-19.”

References

  1. Famotidine (Pepcid) clinical trial shows reduction in COVID-19 symptoms. News release. February 10, 2022. https://www.businesswire.com/news/home/20220210005964/en/Famotidine-Pepcid-Clinical-Trial-Shows-Reduction-in-COVID-19-Symptoms.
  2. Brennan CM, Nadella S, Zhao X, et al. Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial. Gut. Published online: February 10, 2022. doi:10.1136/gutjnl-2022-326952