TY - JOUR T1 - Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial JF - Gut JO - Gut SP - 879 LP - 888 DO - 10.1136/gutjnl-2022-326952 VL - 71 IS - 5 AU - Christina M Brennan AU - Sandeep Nadella AU - Xiang Zhao AU - Richard J Dima AU - Nicole Jordan-Martin AU - Breanna R Demestichas AU - Sam O Kleeman AU - Miriam Ferrer AU - Eva Carlotta von Gablenz AU - Nicholas Mourikis AU - Michael E Rubin AU - Harsha Adnani AU - Hassal Lee AU - Taehoon Ha AU - Soma Prum AU - Cheryl B Schleicher AU - Sharon S Fox AU - Michael G Ryan AU - Christina Pili AU - Gary Goldberg AU - James M Crawford AU - Sara Goodwin AU - Xiaoyue Zhang AU - Jonathan B Preall AU - Ana S H Costa AU - Joseph Conigliaro AU - Joseph R Masci AU - Jie Yang AU - David A Tuveson AU - Kevin J Tracey AU - Tobias Janowitz Y1 - 2022/05/01 UR - http://gut.bmj.com/content/71/5/879.abstract N2 - 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.Data are available upon reasonable request. The gene list for assessing type-I interferon response is provided in Table S5. ER -