Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-01-04 @ 2:48 PM
Study NCT ID:
NCT04351295
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2020-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Faviprevir in COVID-19 Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C462182', 'term': 'favipiravir'}, {'id': 'D002738', 'term': 'Chloroquine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with mortality or need for mechanical ventilation', 'timeFrame': '6 months', 'description': 'Number of patients with mortality or need for mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID']}, 'referencesModule': {'references': [{'pmid': '33492523', 'type': 'DERIVED', 'citation': 'Dabbous HM, Abd-Elsalam S, El-Sayed MH, Sherief AF, Ebeid FFS, El Ghafar MSA, Soliman S, Elbahnasawy M, Badawi R, Tageldin MA. Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study. Arch Virol. 2021 Mar;166(3):949-954. doi: 10.1007/s00705-021-04956-9. Epub 2021 Jan 25.', 'retractions': [{'pmid': '34811571', 'source': 'Arch Virol. 2022 Jan;167(1):277'}]}]}, 'descriptionModule': {'briefSummary': 'Faviprevir in COVID-19 treatment', 'detailedDescription': 'Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with covid 19\n\nExclusion Criteria:\n\n* Allergy or contraindications to faviprevir'}, 'identificationModule': {'nctId': 'NCT04351295', 'briefTitle': 'Efficacy of Faviprevir in COVID-19 Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment', 'orgStudyIdInfo': {'id': 'faviprevir covid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Faviprevir', 'description': 'Faviprevir', 'interventionNames': ['Drug: Favipiravir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chloroquine', 'description': 'chloroquine', 'interventionNames': ['Drug: Chloroquine']}], 'interventions': [{'name': 'Favipiravir', 'type': 'DRUG', 'otherNames': ['Faviprevir'], 'description': 'Favipiravir', 'armGroupLabels': ['Faviprevir']}, {'name': 'Chloroquine', 'type': 'DRUG', 'description': 'chloroquine oral tablets', 'armGroupLabels': ['chloroquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University, Ainshams University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'sherief Abd-Elsalam, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University - Faculty of 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'}}}}