Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-06 @ 10:06 AM
Study NCT ID:
NCT04331834
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2020-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2020-04-01', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed cases of a COVID-19', 'timeFrame': 'Up to 6 months after start of treatment', 'description': 'Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0.'}], 'secondaryOutcomes': [{'measure': 'SARS-CoV-2 seroconversion', 'timeFrame': 'Up to 6 months after start of treatment', 'description': 'SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.'}, {'measure': 'Occurrence of any adverse event related with hydroxychloroquine treatment', 'timeFrame': 'Up to 6 months after start of treatment', 'description': 'Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.'}, {'measure': 'Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers', 'timeFrame': 'Up to 6 months after start of treatment', 'description': 'Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.'}, {'measure': 'Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19', 'timeFrame': 'Up to 6 months after start of treatment'}, {'measure': 'COVID-19 Biobank', 'timeFrame': 'Up to 6 months after start of treatment', 'description': 'A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'hydroxychloroquine', 'prophylaxis', 'pre-exposure', 'healthcare workers'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '34781981', 'type': 'DERIVED', 'citation': 'Grau-Pujol B, Camprubi-Ferrer D, Marti-Soler H, Fernandez-Pardos M, Carreras-Abad C, Andres MV, Ferrer E, Muelas-Fernandez M, Jullien S, Barilaro G, Ajanovic S, Vera I, Moreno L, Gonzalez-Redondo E, Cortes-Serra N, Roldan M, Arcos AA, Mur I, Domingo P, Garcia F, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial. Trials. 2021 Nov 15;22(1):808. doi: 10.1186/s13063-021-05758-9.'}, {'pmid': '32727613', 'type': 'DERIVED', 'citation': 'Grau-Pujol B, Camprubi D, Marti-Soler H, Fernandez-Pardos M, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial. Trials. 2020 Jul 29;21(1):688. doi: 10.1186/s13063-020-04621-7.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Negative PCR and negative serology on day 0\n* Healthcare worker at any of the trial sites\n* Female participants: negative for pregnancy test\n* Willing to participate in the study\n* Able to sign the informed consent form\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Pregnancy or breastfeeding\n* Ongoing antiviral or antiretroviral treatment or HIV positive\n* Ongoing anti-inflammatory treatment (corticosteroids)\n* Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment\n* Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0\n* Positive serology for SARS-CoV-1 infection at day 0\n* Impossibility of signing the informed consent form\n* Rejection of participation\n* Working less than 3 days a week in the Hospital Clinic of Barcelona.\n* Any contraindication for hydroxychloroquine treatment:\n\n * Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity\n * Retinopathy, visual field or visual acuity disturbances\n * QT prolongation, bradycardia (\\<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history\n * Potassium \\< 3 mEq/L or AST or ALT \\> 5 upper normal limit, as determined on day 0 blood test\n * Previous myocardial infarction\n * Myasthenia gravis\n * Porphyria\n * Glomerular clearance \\< 10ml/min\n * Previous history of severe hypoglycaemia\n * Ongoing treatment with antimalarials, antiarrhythmic, tricyclic antidepressants, selective serotonin reuptake inhibitors, natalizumab, quinolones, macrolides, agalsidase alfa and beta.'}, 'identificationModule': {'nctId': 'NCT04331834', 'acronym': 'PrEP_COVID', 'briefTitle': 'Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Barcelona Institute for Global Health'}, 'officialTitle': 'Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PrEP_COVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-exposure prophylaxis of SARS-CoV-2', 'description': 'Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group with placebo', 'description': 'Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Hydroxychloroquine with the following dosage:\n\n* day 0: 400 mg (2 tablets)\n* day 1: 400 mg (2 tablets)\n* day 2: 400 mg (2 tablets)\n* day 3: 400 mg (2 tablets)\n* weekly: 400 mg (2 tablets) for a period of six months', 'armGroupLabels': ['Pre-exposure prophylaxis of SARS-CoV-2']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo with the following dosage:\n\n* day 0: 400 mg (2 tablets)\n* day 1: 400 mg (2 tablets)\n* day 2: 400 mg (2 tablets)\n* day 3: 400 mg (2 tablets)\n* weekly: 400 mg (2 tablets) for a period of six months', 'armGroupLabels': ['Control group with placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'ISGlobal', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Jose Muñoz Gutiérrez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barcelona Institute for Global Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barcelona Institute for Global Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Laboratorios Rubió', 'class': 'UNKNOWN'}, {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, {'name': 'Hospital Plató', 'class': 'OTHER'}, {'name': 'Hospital de Granollers', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}