Famotidine Outpatient COVID-19 Treatment Study

NCT04389567 | Completed FDA Drug

• 1 other identifier: 1605914-1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

Famotidine

Outcome Measures

Primary Outcomes (1)

• Symptomatic improvement

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

  2 weeks

Secondary Outcomes (1)

• Peripheral blood oxygen saturation

  2 weeks

Study Arms (1)

Patients with COVID-19 taking Famotidine

Use of any dose of oral Famotidine during period of COVID-19

Drug: Famotidine

Interventions

Famotidine DRUG

Use of oral Famotidine.

Patients with COVID-19 taking Famotidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study allows participants from all demographics.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Northwell Health: lead
• Cold Spring Harbor Laboratory: collaborator

Study Sites (1)

Cold Spring Harbor Laboratory

Cold Spring Harbor, New York, 11724, United States

Location

Related Publications (2)

• 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.

  PMID: 32292689 BACKGROUND

• 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.

  PMID: 32446698 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David A Tuveson, MD PhD

  Cold Spring Harbor Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 15, 2020
• Study Start: May 12, 2020
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)