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Famotidine Outpatient COVID-19 Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389567
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
Cold Spring Harbor Laboratory
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
COVID-19 Drug: Famotidine

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.(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.

References:

  1. Food and Drug Agency Information Sheet on Famotidine. (1986).
  2. 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).
  3. 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

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with COVID-19 taking Famotidine
Use of any dose of oral Famotidine during period of COVID-19
Drug: Famotidine
Use of oral Famotidine.




Primary Outcome Measures :
  1. Symptomatic improvement [ Time Frame: 2 weeks ]
    Symptoms assessed by severity scores on an ordinal scale; 1=not affected to 4= severely affected


Secondary Outcome Measures :
  1. Peripheral blood oxygen saturation [ Time Frame: 2 weeks ]
    Oxygen saturation determined by pulse oximetry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study allows participants from all demographics.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none


Information from the National Library of Medicine

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


Locations
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United States, New York
Cold Spring Harbor Laboratory
Cold Spring Harbor, New York, United States, 11724
Sponsors and Collaborators
Northwell Health
Cold Spring Harbor Laboratory
Investigators
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Principal Investigator: David A Tuveson, MD PhD Cold Spring Harbor Laboratory
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04389567    
Other Study ID Numbers: 1605914-1
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared with other researchers. De-identified data will be reported in a case series publication. All participants have consented to having de-identified data included in a case series report.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northwell Health:
Famotidine
Additional relevant MeSH terms:
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Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs