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Completed

NCT Number: NCT04389567

Famotidine Outpatient COVID-19 Treatment Study

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cold Spring Harbor Laboratory

Cold Spring Harbor, New York, 11724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

Famotidine

Drug

Use of oral Famotidine.

Primary outcomes

  1. Symptomatic improvement

    Time frame: 2 weeks

    Symptoms assessed by severity scores on an ordinal scale; 1=not affected to 4= severely affected

Secondary outcomes

  1. Peripheral blood oxygen saturation

    Time frame: 2 weeks

    Oxygen saturation determined by pulse oximetry

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Cold Spring Harbor Laboratory

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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