Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-23 @ 10:55 AM
Study NCT ID:
NCT04447534
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2020-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with improvement or mortality', 'timeFrame': '2 weeks', 'description': 'The number of patients with improvement or mortality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID']}, 'referencesModule': {'references': [{'pmid': '33247380', 'type': 'DERIVED', 'citation': 'Abd-Elsalam S, Soliman S, Esmail ES, Khalaf M, Mostafa EF, Medhat MA, Ahmed OA, El Ghafar MSA, Alboraie M, Hassany SM. Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial. Biol Trace Elem Res. 2021 Oct;199(10):3642-3646. doi: 10.1007/s12011-020-02512-1. Epub 2020 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.', 'detailedDescription': 'we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19. As, zinc may be of value in these cases and may be of value in enhancing chloroquine effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with positive COVID-19.\n\nExclusion Criteria:\n\n* Contraindications or hypersensitivity to chloroquine.'}, 'identificationModule': {'nctId': 'NCT04447534', 'briefTitle': 'Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Does Zinc Supplementation Enhance the Clinical Efficacy of Chloroquine/Hydroxychloroquine in Treatment of COVID-19?', 'orgStudyIdInfo': {'id': 'tanta zinc chloroquine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chloroquine or hydroxychloroquine', 'description': 'Chloroquine or hydroxychloroquine alone', 'interventionNames': ['Drug: Chloroquine or hydroxychloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Chloroquine or hydroxychloroquine with zinc', 'description': 'Chloroquine or hydroxychloroquine with zinc', 'interventionNames': ['Drug: Chloroquine or hydroxychloroquine', 'Drug: zinc']}], 'interventions': [{'name': 'Chloroquine or hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['alexoquine, chloroquine, hydroquine'], 'description': 'Chloroquine or hydroxychloroquine', 'armGroupLabels': ['Chloroquine or hydroxychloroquine', 'Chloroquine or hydroxychloroquine with zinc']}, {'name': 'zinc', 'type': 'DRUG', 'description': 'Zinc tablets', 'armGroupLabels': ['Chloroquine or hydroxychloroquine with zinc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta university hospital, Assuit University, Ainshams University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'sherief Abd-Elsalam, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ass. Prof. Tropical Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof. Tropical Medicine', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}