Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT04363450
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be randomized to the investigational drug (hydroxychloroquine) or placebo. Both will have identical appearance and will be taken at the same dosing interval. The administration of the drug and assessment will be blinded. After final analysis, study arms will be unmasked.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo-controlled, double-blind study with 1:1 randomization of hydroxychloroquine to placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of symptomatic COVID-19 infection in healthcare workers', 'timeFrame': '12 weeks', 'description': 'Number of participants who develop symptoms of COVID-19 in the setting of a positive COVID-19 assay'}], 'secondaryOutcomes': [{'measure': 'Absenteeism from work due to COVID-19', 'timeFrame': '12 weeks', 'description': 'Number of days healthcare workers are absent from work due to symptomatic COVID-19 infection'}, {'measure': 'Severity of COVID-19 infection', 'timeFrame': '12 weeks', 'description': 'Rate of severe COVID-19 infection in healthcare works (hypoxia in setting of chest imaging \\>50% lung involvement, respiratory failure, end organ damage or shock)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'COVID-19 Prophylaxis', 'Healthcare Workers', 'SARS-COV-2', 'Hydroxychloroquine'], 'conditions': ['COVID-19', 'Corona Virus Infection', 'Wuhan Coronavirus', 'Prophylaxis', 'Healthcare Worker', 'Sars-CoV2', 'Hydroxychloroquine']}, 'descriptionModule': {'briefSummary': 'This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.', 'detailedDescription': 'The study is a double blind placebo controlled at two hospitals in Lafayette, Louisiana aiming to enroll 1700 participants with a 1:1 randomization. The HCQ dose in 400mg twice on day 1, then 200mg twice weekly. The primary outcome variable is development of symptomatic COVID-19 infection. The secondary objectives are number of days absent from work due to symptomatic COVID-19 infection and rate of severe disease due to COVID-19 (hypoxia in setting of \\>50% lung involvement on chest imaging, respiratory failure, shock or end-organ damage). The study will enroll participants for four weeks with and plan to treat with hydroxychloroquine versus placebo for a total of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Healthcare or Hospital Worker who has direct patient contact\n3. Willing to participate in the research.\n4. Able to understand and sign the informed consent form\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics\n3. Known prolonged QTc interval\n4. History of retinal disease\n5. Kidney failure with GFR \\<10%\n6. Chronic hepatic disease w/ Child-Pugh class B or C\n7. Hypersensitivity to chloroquine or hydroxychloroquine\n8. Currently taking chloroquine or hydroxychloroquine\n9. Unwilling to participate\n10. Unable to understand and/or sign the informed consent form.'}, 'identificationModule': {'nctId': 'NCT04363450', 'acronym': 'HCQPreP', 'briefTitle': 'Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)', 'orgStudyIdInfo': {'id': 'LSU NO HSC IRB 20-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine loading dose will be given as 400mg for two doses 12 hours apart. This will then be followed by maintenance dosing of 200mg twice weekly for the remainder of the trial.', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An identical placebo will be administered on an identical dosing interval and frequency.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['HCQ PreP'], 'description': 'Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann D Chauffe, DO, MPH', 'role': 'CONTACT', 'email': 'achauf@lsuhsc.edu', 'phone': '337-261-6000'}, {'name': 'Rebecca B Lee, DO, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicholas Sells, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'James B Falterman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carl Sabottke, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Stouts, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ann D Chauffe, DO, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lafayette General Medical Center', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '70506', 'city': 'Lafayette', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann D Chauffe, DO, MPH', 'role': 'CONTACT', 'email': 'achauf@lsuhsc.edu', 'phone': '337-261-6000'}, {'name': 'Ann D Chauffe, DO, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rebecca B Lee, DO, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicholas Sells, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'James B Falterman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carl Sabottke, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Stout, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital and Clinics', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}], 'centralContacts': [{'name': 'Ann D. Chauffe, DO, MPH', 'role': 'CONTACT', 'email': 'achauf@lsuhsc.edu', 'phone': '337-261-6161'}, {'name': 'Rebecca B. Lee, DO, MS', 'role': 'CONTACT', 'email': 'rlee10@lsuhsc.edu', 'phone': '337-261-6000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lafayette General Health', 'class': 'OTHER'}, {'name': 'University of Louisiana at Lafayette', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DO, MPH', 'investigatorFullName': 'Ann Chauffe', 'investigatorAffiliation': 'Louisiana State University Health Sciences Center in New Orleans'}}}}