Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
Study NCT ID:
NCT04342650
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2020-04-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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': 'C023676', 'term': 'chloroquine diphosphate'}, {'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2020-04-04', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with onset of severe acute respiratory syndrome (SARS)', 'timeFrame': '7 days after randomization', 'description': 'Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': 'after randomization, up to 28 days', 'description': 'Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization'}, {'measure': 'Number of participants in need of intensive care support', 'timeFrame': 'during and after intervention, up to 28 days', 'description': 'Proportion of participants in need and duration of intensive care support after randomization'}, {'measure': 'Viral concentration', 'timeFrame': 'After randomization, up to 7 days', 'description': 'Viral load change in blood and oropharyngeal swab samples'}, {'measure': 'Cumulative incidence of serious adverse events', 'timeFrame': 'During and after intervention, up to 28 days', 'description': 'Incidence of serious adverse events during and after treatment'}, {'measure': 'Cumulative incidence of grade 3 and 4 adverse events', 'timeFrame': 'During and after intervention, up to 28 days', 'description': 'Incidence of grade 3 and 4 adverse events during and after treatment'}, {'measure': 'Proportion of patients with discontinued treatment', 'timeFrame': 'after randomization, up to 28 days', 'description': 'proportion of discontinuation or temporary suspension of treatment (for any reason)'}, {'measure': 'Incidence of cardiac lesions', 'timeFrame': 'after randomization, up to 120 days', 'description': 'proportion of patients with increased levels of troponin I'}, {'measure': 'Incidence of cardiac disfunctions', 'timeFrame': 'after randomization, up to 120 days', 'description': 'proportion and magnitude of QTcF interval increases higher than 500ms'}, {'measure': 'Change in respiratory capacity', 'timeFrame': 'Day 120 after randomization', 'description': 'Changes measured on day 120 will be compared to baseline, through spirometry.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'SARS-CoV Infection', 'Severe Acute Respiratory Syndrome (SARS) Pneumonia', 'Clinical Trial']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;\n2. Adult aged 18 or over, at the time of inclusion\n3. Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation\\> 94% in room air, and having a respiratory rate below 24 incursions per minute.\n4. Patients with comorbidities only, due to the increased risk of developing SARS\n\nExclusion Criteria:\n\n1\\. Patients with chronic use of drugs known to prolong QTc interval.'}, 'identificationModule': {'nctId': 'NCT04342650', 'acronym': 'CloroCOVID19II', 'briefTitle': 'Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado'}, 'officialTitle': 'Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CAAE: 30504220.5.0000.0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'CQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration.', 'interventionNames': ['Drug: Chloroquine Diphosphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tables of equal characteristics and duration of treatment.', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Chloroquine Diphosphate', 'type': 'DRUG', 'otherNames': ['chloroquine'], 'description': '150mg tablets Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': '150mg placebo tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69093-415', 'city': 'Manaus', 'state': 'Amazonas', 'country': 'Brazil', 'facility': 'Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'after study publication', 'ipdSharing': 'YES', 'description': 'all patient data will be shared after study publication', 'accessCriteria': 'Upon formal request to researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}