Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial.
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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
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 SH
Conigliaro, Joseph
Masci, Joseph R
Yang, Jie
Tracey, Kevin J
Publication Date
2022-05Journal Title
Gut
ISSN
0017-5749
Publisher
BMJ
Language
eng
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Brennan, C. M., Nadella, S., Zhao, X., Dima, R. J., Jordan-Martin, N., Demestichas, B. R., Kleeman, S. O., et al. (2022). Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial.. Gut https://doi.org/10.1136/gutjnl-2022-326952
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.
Keywords
Interferon, Inflammation, Clinical Trials, Covid-19
Sponsorship
NCI NIH HHS (P30 CA045508)
NIGMS NIH HHS (R35 GM118182)
Identifiers
PMC8844971, 35144974
External DOI: https://doi.org/10.1136/gutjnl-2022-326952
This record's URL: https://www.repository.cam.ac.uk/handle/1810/334995
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