Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
Study NCT ID:
NCT04350450
Status:
WITHDRAWN
Last Update Posted:
2020-05-27
First Post:
2020-04-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI withdrew the submission to the IRB', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to resolution of symptoms', 'timeFrame': 'up to 4 weeks', 'description': 'Time that it takes for symptoms to be resolved in those who were treated vs untreated'}], 'secondaryOutcomes': [{'measure': 'Number of days from onset of illness to symptom resolution', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Number of days to return to work', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Rate of hospital admission in treated and untreated healthcare workers', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Adverse effect of HCQ during treatment', 'timeFrame': 'up to 5 days'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'Coronavirus', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect clinical symptoms)\n* Call into office within the first 7 days of illness\n* Have any of the following high risk conditions:\n\n * Age \\>60\n * HTN, CAD, or chronic heart disease\n * Diabetes\n * Chronic kidney disease\n * Chronic lung disease\n * Active or recent chemotherapy for malignancy\n * Organ transplant\n * Taking Immune-suppressing medications\n * HIV with CD4 \\<200 cells/mm3\n* Experiencing at least one of the following high risk symptoms:\n\n * Severe cough\n * Fever 100.0F or greater\n * Diarrhea\n * Shortness of Breath\n * Hypoxia\n\nExclusion Criteria:\n\n• HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ'}, 'identificationModule': {'nctId': 'NCT04350450', 'briefTitle': 'Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes', 'orgStudyIdInfo': {'id': '2020-11445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Eligible participants will be offered the standard Montefiore HCQ dosing regimen of 400mg every 12 hours x 24 hours, then 400mg daily for remaining 4 days and complete a survey study', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants who opt not to receive the study drug will also be invited to participate in the survey study assessing COVID19 symptoms'}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': '400 mg tablet', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Priya Nori, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Priya Nori', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}