Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-31 @ 6:14 AM
Study NCT ID:
NCT04445467
Status:
UNKNOWN
Last Update Posted:
2021-10-07
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Adaptive Clinical Trial of Antivirals for COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C462182', 'term': 'favipiravir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to virological cure', 'timeFrame': '14 days', 'description': 'Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '28 days', 'description': 'All adverse events definitely, probably or possibly related to study treatment.'}, {'measure': 'Clinical improvement', 'timeFrame': '28 days', 'description': 'Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale'}, {'measure': 'Clinical symptoms', 'timeFrame': '28 days', 'description': 'Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours'}, {'measure': 'Biomarkers', 'timeFrame': '28 days', 'description': 'Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID']}, 'referencesModule': {'references': [{'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}, {'pmid': '33050947', 'type': 'DERIVED', 'citation': 'McMahon JH, Lau JSY, Roney J, Rogers BA, Trubiano J, Sasadeusz J, Molton JS, Gardiner B, Lee SJ, Hoy JF, Cheng A, Peleg AY. An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 13;21(1):847. doi: 10.1186/s13063-020-04766-5.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent by the participant or authorized representative\n* Age ≥18 years\n* Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days\n* COVID-19 related symptom initiation within 5 days\n* Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.\n\nExclusion Criteria:\n\n* Known allergy to the study medication\n* Is on another antiviral for the treatment of COVID-19\n* Pregnancy\n* Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification\n* Patients with renal impairment requiring dialysis\n* Is deemed by the Investigator to be ineligible for any reason'}, 'identificationModule': {'nctId': 'NCT04445467', 'acronym': 'VIRCO', 'briefTitle': 'An Adaptive Clinical Trial of Antivirals for COVID-19 Infection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection', 'orgStudyIdInfo': {'id': '66223'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Favipiravir', 'description': '1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.', 'interventionNames': ['Drug: Favipiravir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched Placebo', 'interventionNames': ['Drug: Favipiravir']}], 'interventions': [{'name': 'Favipiravir', 'type': 'DRUG', 'description': 'Favipiravir', 'armGroupLabels': ['Favipiravir', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}