Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT04429867
Status:
UNKNOWN
Last Update Posted:
2020-06-16
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.', 'timeFrame': '30 Days', 'description': 'The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': '30 Days'}, {'measure': '30-Day Mortality', 'timeFrame': '30 Days'}, {'measure': 'Resolution of Symptoms', 'timeFrame': '14 Days', 'description': 'Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.'}, {'measure': 'Incidence of QTc >500ms after initiation of therapy', 'timeFrame': '30 Days'}, {'measure': 'Incidence of discontinuation of therapy', 'timeFrame': '30 Days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.', 'detailedDescription': 'This study will utilize a randomized, placebo-controlled, double-blinded design. Patients admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on CT/CXR, age \\>65, diabetes, hypertension, BMI \\> 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to Wellstar Kennestone Hospital\n* Age 18 years or older\n* Laboratory-confirmed COVID-19\n* At least 1 of the following:\n\n 1. Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline\n 2. Bilateral infiltrates on CXR or CT of chest\n 3. Age 65 or older\n 4. Diabetes\n 5. Hypertension\n 6. BMI \\> 35\n 7. Chronic lung disease\n 8. Cardiovascular disease\n 9. Chronic kidney disease\n 10. Cancer (hematologic malignancies, lung cancer, and metastatic disease)\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Unable to take oral medication\n* Severe/critical COVID-19 disease at presentation\n\n 1. Intensive care or intermediate care required at admission or within 48 hours\n 2. Requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours\n* Likelihood of survival \\<48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission\n* Inability to take hydroxychloroquine due to allergy, QTc \\> 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions\n* Pregnant or breastfeeding\n* Severe liver disease (Child-Pugh Class C)'}, 'identificationModule': {'nctId': 'NCT04429867', 'briefTitle': 'Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease', 'organization': {'class': 'OTHER', 'fullName': 'WellStar Health System'}, 'officialTitle': 'Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease', 'orgStudyIdInfo': {'id': '1604885'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar Kennestone Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WellStar Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}