Your browser doesn't support javascript.
Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial.
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.
  • Brennan CM; Office of Clinical Research, Northwell Health, Lake Success, New York, USA.
  • Nadella S; Feinstein Institutes for Medical Research, Manhasset, New York, USA.
  • Zhao X; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
  • Dima RJ; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Jordan-Martin N; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Demestichas BR; Office of Clinical Research, Northwell Health, Lake Success, New York, USA.
  • Kleeman SO; New York City Helath + Hospitals Corporation, New York, New York, USA.
  • Ferrer M; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • von Gablenz EC; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Mourikis N; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Rubin ME; Medical Research Council Cancer Unit, University of Cambridge, Hutchison Research Centre, Cambridge, UK.
  • Adnani H; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Lee H; Medical School, University of Heidelberg, Heidelberg, Germany.
  • Ha T; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Prum S; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Schleicher CB; Office of Clinical Research, Northwell Health, Lake Success, New York, USA.
  • Fox SS; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Ryan MG; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Pili C; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Goldberg G; Northwell Health Cancer Institute, Northwell Health, New Hyde Park, New York, USA.
  • Crawford JM; Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
  • Goodwin S; Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
  • Zhang X; Feinstein Institutes for Medical Research, Manhasset, New York, USA.
  • Preall JB; New York City Helath + Hospitals Corporation, New York, New York, USA.
  • Costa ASH; Department of Obstetrics and Gynecology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
  • Conigliaro J; Department of Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
  • Masci JR; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Yang J; Biostatistical Consulting Core, School of Medicine, Stony Brook University, Stony Brook, New York, USA.
  • Tuveson DA; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Tracey KJ; Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.
  • Janowitz T; Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
Gut ; 71(5): 879-888, 2022 05.
Article in English | MEDLINE | ID: covidwho-1685682
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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Famotidine / COVID-19 Drug Treatment Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans Language: English Journal: Gut Year: 2022 Document Type: Article Affiliation country: Gutjnl-2022-326952

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Famotidine / COVID-19 Drug Treatment Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans Language: English Journal: Gut Year: 2022 Document Type: Article Affiliation country: Gutjnl-2022-326952