Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 8:53 PM
Study NCT ID:
NCT04389567
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Famotidine Outpatient COVID-19 Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic improvement', 'timeFrame': '2 weeks', 'description': 'Symptoms assessed by severity scores on an ordinal scale; 1=not affected to 4= severely affected'}], 'secondaryOutcomes': [{'measure': 'Peripheral blood oxygen saturation', 'timeFrame': '2 weeks', 'description': 'Oxygen saturation determined by pulse oximetry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Famotidine'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32292689', 'type': 'BACKGROUND', 'citation': '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': '32446698', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nInclusion criteria:\n\nAge\\>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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study allows participants from all demographics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\>18 years; Ability to give written informed consent; Confirmed COVID-19 diagnosis; Famotidine use during COVID-19 illness\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT04389567', 'briefTitle': 'Famotidine Outpatient COVID-19 Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Famotidine Use in Non-hospitalized Patients With COVID-19: A Case Series', 'orgStudyIdInfo': {'id': '1605914-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COVID-19 taking Famotidine', 'description': 'Use of any dose of oral Famotidine during period of COVID-19', 'interventionNames': ['Drug: Famotidine']}], 'interventions': [{'name': 'Famotidine', 'type': 'DRUG', 'description': 'Use of oral Famotidine.', 'armGroupLabels': ['Patients with COVID-19 taking Famotidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11724', 'city': 'Cold Spring Harbor', 'state': 'New York', 'country': 'United States', 'facility': 'Cold Spring Harbor Laboratory', 'geoPoint': {'lat': 40.87149, 'lon': -73.45679}}], 'overallOfficials': [{'name': 'David A Tuveson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cold Spring Harbor Laboratory'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cold Spring Harbor Laboratory', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}