Famotidine Outpatient COVID-19 Treatment Study
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|ClinicalTrials.gov Identifier: NCT04389567|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
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.
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
|Condition or disease||Intervention/treatment|
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.(1) In computer-based simulations, Famotidine has been identified as a potential inhibitor of the 3-chymotrypsin-like protease (3CLpro).(2) 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.(3) 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.
- Food and Drug Agency Information Sheet on Famotidine. (1986).
- Wu, C. et al. Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods. Acta Pharm. Sin. B (2020).
- Freedberg, D. E. et al. Famotidine Use is Associated with Improved Clinical Outcomes in Hospitalized COVID-19 Patients : A Propensity Score Matched Retrospective Cohort Study. (2020), pre-print published on MedRxiv
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Famotidine Use in Non-hospitalized Patients With COVID-19: A Case Series|
|Actual Study Start Date :||May 12, 2020|
|Estimated Primary Completion Date :||May 20, 2020|
|Estimated Study Completion Date :||May 20, 2020|
Patients with COVID-19 taking Famotidine
Use of any dose of oral Famotidine during period of COVID-19
Use of oral Famotidine.
- Symptomatic improvement [ Time Frame: 2 weeks ]Symptoms assessed by severity scores on an ordinal scale; 1=not affected to 4= severely affected
- Peripheral blood oxygen saturation [ Time Frame: 2 weeks ]Oxygen saturation determined by pulse oximetry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389567
|United States, New York|
|Cold Spring Harbor Laboratory|
|Cold Spring Harbor, New York, United States, 11724|
|Principal Investigator:||David A Tuveson, MD PhD||Cold Spring Harbor Laboratory|