Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial. Issue 5 (10th February 2022)

• Record Type: Journal Article
• Authors: Brennan, Christina M; Nadella, Sandeep; Zhao, Xiang; Dima, Richard J; Jordan-Martin, Nicole; Demestichas, Breanna R; Kleeman, Sam O; Ferrer, Miriam; von Gablenz, Eva Carlotta; Mourikis, Nicholas; Rubin, Michael E; Adnani, Harsha; Lee, Hassal; Ha, Taehoon; Prum, Soma; Schleicher, Cheryl B; Fox, Sharon S; Ryan, Michael G; Pili, Christina; Goldberg, Gary; Crawford, James M; Goodwin, Sara; Zhang, Xiaoyue; Preall, Jonathan B; Costa, Ana S H; Conigliaro, Joseph; Masci, Joseph R; Yang, Jie; Tuveson, David A; Tracey, Kevin J; Janowitz, Tobias;
• Is Part Of: Gut. Volume 71:Issue 5(2022)
• Page Start: 879
• Page End: 888
• Publication Date: 2022-02-10
• Subjects: COVID-19 -- clinical trials -- inflammation -- interferon; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2022-326952
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : Objective: We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19. Design: Randomised, double-blind, placebo-controlled, fully remote, phase 2 clinical trial (NCT04724720 ) enrolling symptomatic unvaccinated adult outpatients with confirmed COVID-19 between January 2021 and April 2021 from two US centres. Patients self-administered 80 mg famotidine (n=28) or placebo (n=27) orally three times a day for 14 consecutive days. Endpoints were time to (primary) or rate of (secondary) symptom resolution, and resolution of inflammation (exploratory). Results: Of 55 patients in the intention-to-treat group (median age 35 years (IQR: 20); 35 women (64%); 18 African American (33%); 14 Hispanic (26%)), 52 (95%) completed the trial, submitting 1358 electronic symptom surveys. Time to symptom resolution was not statistically improved (p=0.4). Rate of symptom resolution was improved for patients taking famotidine (p<0.0001). Estimated 50% reduction of overall baseline symptom scores were achieved at 8.2 days (95% CI: 7 to 9.8 days) for famotidine and 11.4 days (95% CI: 10.3 to 12.6 days) for placebo treated patients. Differences were independent of patient sex, race or ethnicity. Five self-limiting adverse events occurred (famotidine, n=2 (40%); placebo, n=3 (60%)). On day 7, fewer patients on famotidine had detectable interferon alpha plasma levels (p=0.04). Plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein were similar between both arms. Conclusions: Famotidine was safe and well tolerated in outpatients with mild to moderate COVID-19. Famotidine led to earlier resolution of symptoms and inflammation without reducing anti-SARS-CoV-2 immunity. Additional randomised trials are required.