Famotidine Outpatient COVID-19 Treatment Study

COVID-19 Clinical Trial

Official title:

Famotidine Use in Non-hospitalized Patients With COVID-19: A Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389567
• Other study ID #: 1605914-1
• Status: Completed
• Start date: May 12, 2020
• Est. completion date: May 25, 2020

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective case series of patients who self-medicated with Famotidine during coronavirus disease 2019 (COVID-19). The study will collect de-identified patient reported outcome measures of patients with confirmed COVID-19 who self-medicated with Famotidine at any dose during the period of illness. Data will be collected by questionnaire and telephone interview.

Inclusion criteria:

Age>18; Ability to give written informed consent for study participation; Confirmed diagnosis of COVID-19; Use of Famotidine at any dose during period of COVID-19 illness

Description:

Famotidine is a histamine-2 receptor antagonist, widely available over-the-counter, and is safely used for suppression of gastric acid production over a wide range of doses from 20mg once daily to 160mg four times daily. In computer-based simulations, Famotidine has been identified as a potential inhibitor of the 3-chymotrypsin-like protease (3CLpro). In a propensity score matched retrospective cohort study a significantly reduced risk for death or intubation (adjusted hazard ratio 0.43, 95% confidence interval 0.21-0.88) was identified for patients with COVID-19 who were taking Famotidine before or at the point of hospital admission. Some individuals have self-medicated with Famotidine while being outpatients with COVID-19. This study is aimed at collecting patient reported outcome measures from such individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 25, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age >18 years; Ability to give written informed consent; Confirmed COVID-19 diagnosis; Famotidine use during COVID-19 illness

Exclusion Criteria:

none

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Famotidine
Use of oral Famotidine.

Locations

Country	Name	City	State
United States	Cold Spring Harbor Laboratory	Cold Spring Harbor	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Cold Spring Harbor Laboratory

Country where clinical trial is conducted

United States, 

References & Publications (2)

Freedberg DE, Conigliaro J, Wang TC, Tracey KJ, Callahan MV, Abrams JA; Famotidine Research Group. Famotidine Use Is Associated With Improved Clinical Outcomes in Hospitalized COVID-19 Patients: A Propensity Score Matched Retrospective Cohort Study. Gastroenterology. 2020 Sep;159(3):1129-1131.e3. doi: 10.1053/j.gastro.2020.05.053. Epub 2020 May 22. No abstract available. — View Citation

Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, Wang Q, Xu Y, Li M, Li X, Zheng M, Chen L, Li H. Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods. Acta Pharm Sin B. 2020 May;10(5):766-788. doi: 10.1016/j.apsb.2020.02.008. Epub 2020 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic improvement	Symptoms assessed by severity scores on an ordinal scale; 1=not affected to 4= severely affected	2 weeks
Secondary	Peripheral blood oxygen saturation	Oxygen saturation determined by pulse oximetry	2 weeks