RT Journal Article
SR Electronic
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
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 879
OP 888
DO 10.1136/gutjnl-2022-326952
VO 71
IS 5
A1 Brennan, Christina M
A1 Nadella, Sandeep
A1 Zhao, Xiang
A1 Dima, Richard J
A1 Jordan-Martin, Nicole
A1 Demestichas, Breanna R
A1 Kleeman, Sam O
A1 Ferrer, Miriam
A1 von Gablenz, Eva Carlotta
A1 Mourikis, Nicholas
A1 Rubin, Michael E
A1 Adnani, Harsha
A1 Lee, Hassal
A1 Ha, Taehoon
A1 Prum, Soma
A1 Schleicher, Cheryl B
A1 Fox, Sharon S
A1 Ryan, Michael G
A1 Pili, Christina
A1 Goldberg, Gary
A1 Crawford, James M
A1 Goodwin, Sara
A1 Zhang, Xiaoyue
A1 Preall, Jonathan B
A1 Costa, Ana S H
A1 Conigliaro, Joseph
A1 Masci, Joseph R
A1 Yang, Jie
A1 Tuveson, David A
A1 Tracey, Kevin J
A1 Janowitz, Tobias
YR 2022
UL http://gut.bmj.com/content/71/5/879.abstract
AB 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.