Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
Study NCT ID:
NCT04349228
Status:
WITHDRAWN
Last Update Posted:
2020-08-28
First Post:
2020-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals
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': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'As the trial is open-label and to preserve the validity of the trial, the measurement of the endpoint must be blinded by a third party (i.e., an evaluator who is not aware of the arm to which the patient has been assigned or the treatment the patient is receiving) using the PROBE ("Prospective Randomized Open Blinded Endpoint") method.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Arm1:Hydroxychloroquine (HCQ) (200 mg / day) for at least 2 months or until potential contamination\\*\\*.\n\nArm2:Placebo (1 tablet/day) for at least 2 months or until potential contamination\\*\\*.\n\n\\*\\* If the participant is contaminated (COVID19+), he or she will be followed up by telephone according to the study schedule.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': '\\- Interest in the use of HCQ is controversial.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic COVID(+) infection rate', 'timeFrame': '60 days', 'description': '* Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below:\n* Cough\n* Dyspnea\n* Fever\n* Myalgia\n* Arthralgia\n* Rhinorrhea\n* Anosmia\n* Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period.\n* Biological Examination :\n* Measurement of viral load\n* Ion, liver, kidney, haematological assessment\n* Electrical Examination: ECG'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCQ', 'prophylaxie', 'Healthcare Worker', 'Hydroxychloroquine', 'COVID19'], 'conditions': ['COVID19', 'Sars-CoV2', 'Hydroxychloroquine', 'Prophylaxis', 'Healthcare Worker']}, 'descriptionModule': {'briefSummary': 'Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study', 'detailedDescription': 'Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COVID-19 (-)\n* Works in a medical intensive care unit exposed to COVID-19 infection\n* 18 years old \\< age \\< 65 years old\n* Having given written consent for their participation in the study.\n\nExclusion Criteria:\n\n* Diagnosis of COVID-19+\n* Retinopathies,\n* Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study.\n* Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug,\n* Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance \\< 30 ml/min.\n* Inability to be monitored during the trial period\n* Pregnancy and breastfeeding\n* Psoriasis'}, 'identificationModule': {'nctId': 'NCT04349228', 'acronym': 'COVID_2Pro', 'briefTitle': 'Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Abderrahmane Mami Hospital'}, 'officialTitle': 'Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study', 'orgStudyIdInfo': {'id': 'ECC2020-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine (HCQ)', 'description': 'Exposed health care professionals working in the intensive care unit', 'interventionNames': ['Drug: Hydroxychloroquine (HCQ)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Exposed health care professionals working in the intensive care unit', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Hydroxychloroquine (HCQ)', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': 'Hydroxychloroquine (HCQ) 200mg/day', 'armGroupLabels': ['Hydroxychloroquine (HCQ)']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'otherNames': ['Placebo of Plaquenil'], 'description': 'Placebo of Hydroxychloroquine (HCQ) without any active substance', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Jalila Ben Khelil, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Abderrahmane Mami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abderrahmane Mami Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eshmoun Clinical Research Center', 'class': 'NETWORK'}, {'name': 'Datametrix', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department', 'investigatorFullName': 'Dr Jalila Ben Khelil', 'investigatorAffiliation': 'Abderrahmane Mami Hospital'}}}}