Famotidine Outpatient COVID-19 Treatment Study

Completed

• Conditions: COVID-19
• Interventions: Drug: Famotidine

• Registration Number: NCT04389567
• Lead Sponsor: Northwell Health

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2020-05-12
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-15
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with COVID-19 taking Famotidine	Famotidine	Use of any dose of oral Famotidine during period of COVID-19

Primary Outcome Measures

Name	Time	Method
Symptomatic improvement	2 weeks	Symptoms assessed by severity scores on an ordinal scale; 1=not affected to 4= severely affected

Secondary Outcome Measures

Name	Time	Method
Peripheral blood oxygen saturation	2 weeks	Oxygen saturation determined by pulse oximetry

Trial Locations

Locations (1)

Cold Spring Harbor Laboratory; 🇺🇸 Cold Spring Harbor, New York, United States