Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT04621461
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2020-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019287', 'term': 'Zinc Sulfate'}], 'ancestors': [{'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017967', 'term': 'Zinc Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Patients will be randomized via a randomization block. Only the research coordinator will know which group the patients belong to. Placebo pills given to the patient will be similar in size and shape to zinc.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population. Patients will randomized to zinc or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants hospitalized and/or requiring repeat emergency room visits', 'timeFrame': '21 days', 'description': 'COVID-19 related complications that require the participant to be hospitalized or have an emergency room visit'}, {'measure': 'Number of participants admitted to the Intensive care unit (ICU)', 'timeFrame': '30 days', 'description': 'If hospitalized, number of participants admitted to the ICU, and number of days in the ICU'}, {'measure': 'Number of participants on a ventilator', 'timeFrame': '30 days', 'description': 'If placed on ventilator, number of days on a ventilator'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'Up to 30 days', 'description': 'Total number of deaths in the cohort.'}, {'measure': 'Time to resolution of COVID-19 symptoms', 'timeFrame': 'Evaluated at day 2, 6, day 14, and day 21', 'description': 'Time at which the patient is completely symptom free.'}, {'measure': 'Severity of symptoms', 'timeFrame': 'Evaluated at day 2, 6, day 14, and day 21', 'description': 'Scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Zinc'], 'conditions': ['Corona Virus Infection']}, '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': '176466', 'type': 'BACKGROUND', 'citation': 'Korant BD, Butterworth BE. Inhibition by zinc of rhinovirus protein cleavage: interaction of zinc with capsid polypeptides. J Virol. 1976 Apr;18(1):298-306. doi: 10.1128/JVI.18.1.298-306.1976.'}, {'pmid': '7347557', 'type': 'BACKGROUND', 'citation': 'Katz E, Margalith E. Inhibition of vaccinia virus maturation by zinc chloride. Antimicrob Agents Chemother. 1981 Feb;19(2):213-7. doi: 10.1128/AAC.19.2.213.'}, {'pmid': '2177090', 'type': 'BACKGROUND', 'citation': 'Kumel G, Schrader S, Zentgraf H, Daus H, Brendel M. The mechanism of the antiherpetic activity of zinc sulphate. J Gen Virol. 1990 Dec;71 ( Pt 12):2989-97. doi: 10.1099/0022-1317-71-12-2989.'}, {'pmid': '14982765', 'type': 'BACKGROUND', 'citation': 'Suara RO, Crowe JE Jr. Effect of zinc salts on respiratory syncytial virus replication. Antimicrob Agents Chemother. 2004 Mar;48(3):783-90. doi: 10.1128/AAC.48.3.783-790.2004.'}, {'pmid': '6367635', 'type': 'BACKGROUND', 'citation': 'Eby GA, Davis DR, Halcomb WW. Reduction in duration of common colds by zinc gluconate lozenges in a double-blind study. Antimicrob Agents Chemother. 1984 Jan;25(1):20-4. doi: 10.1128/AAC.25.1.20.'}, {'pmid': '21079686', 'type': 'BACKGROUND', 'citation': 'te Velthuis AJ, van den Worm SH, Sims AC, Baric RS, Snijder EJ, van Hemert MJ. Zn(2+) inhibits coronavirus and arterivirus RNA polymerase activity in vitro and zinc ionophores block the replication of these viruses in cell culture. PLoS Pathog. 2010 Nov 4;6(11):e1001176. doi: 10.1371/journal.ppat.1001176.'}, {'pmid': '23775705', 'type': 'BACKGROUND', 'citation': 'Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.'}, {'pmid': '16284213', 'type': 'BACKGROUND', 'citation': 'Bao S, Knoell DL. Zinc modulates airway epithelium susceptibility to death receptor-mediated apoptosis. Am J Physiol Lung Cell Mol Physiol. 2006 Mar;290(3):L433-41. doi: 10.1152/ajplung.00341.2005. Epub 2005 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.', 'detailedDescription': 'Zinc, a micronutrient, appears to have anti-viral properties with various mechanisms of action depending on the concentration Zinc supplementation has been reviewed extensively for use in the common cold, and has been shown to reduce the duration of symptoms. In-vitro studies have shown zinc can inhibit RNA-dependent RNA polymerase (RdRP) in coronavirus, which is typically a conserved region in the viral genome. In-vitro experiments have also shown that lung epithelium in a zinc depleted state can become susceptible to apoptosis and loss of barrier function, increasing permeability, which can lead to acute respiratory distress syndrome (ARDS).\n\nIf a patient can travel to St. Francis Hospital they can have a COVID test on site at a designated St. Francis testing location. The COVID test will be resulted via a rapid Covid (Point of Care device) or at a local lab.\n\nPatients who are unable to travel to St. Francis Hospital or one of the outpatient practices, will be allowed to enroll remotely. Patients are eligible to enroll within 72 hours of a positive Covid-19 test result. Study medications will be mailed to the patient overnight after being enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and understand informed consent.\n* High initial clinical suspicion by physician based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by confirmation of COVID-19 diagnosis\n* Any gender\n* Age 60 years and older\n* Age 30-59 years with one or more of the following:\n\n * abnormal lung exam\n * abnormal oxygen saturation \\<95%\n * abnormal Chest X-ray or chest CT\n * persistent fever \\>100.4 degrees Fahrenheit\n * one of the following co-morbidities: hypertension, diabetes mellitus, history of coronary artery disease, chronic kidney disease (CKD), asthma, COPD, current or former smoker, or morbid obesity (Body Mass Index ≥35)\n\nExclusion Criteria:\n\n* Severe COVID-19 requiring admission for inpatient treatment\n* Need for any oxygen supplementation\n* Need for mechanical ventilatory support\n* History of oxygen supplementation dependency\n* History of cancer with ongoing chemotherapy or radiation therapy\n* Known hypersensitivity to zinc\n* Severe renal disease: Glomerular Filtration Rate \\<30ml/min'}, 'identificationModule': {'nctId': 'NCT04621461', 'briefTitle': 'Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting', 'organization': {'class': 'OTHER', 'fullName': 'St. Francis Hospital, New York'}, 'officialTitle': 'A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting', 'orgStudyIdInfo': {'id': '20-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Experimental Arm #1', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm #2', 'description': 'Zinc sulfate', 'interventionNames': ['Dietary Supplement: Zinc Sulfate 220 MG']}], 'interventions': [{'name': 'Zinc Sulfate 220 MG', 'type': 'DIETARY_SUPPLEMENT', 'description': '220mg once daily for 5 days', 'armGroupLabels': ['Experimental Arm #2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily for 5 days', 'armGroupLabels': ['Experimental Arm #1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'St. Francis Hospital - The Heart Center', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}], 'overallOfficials': [{'name': 'Avni Thakore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Francis Hospital - The Heart Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Francis Hospital, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}