Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04476602
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Admission', 'timeFrame': '30 days', 'description': 'admission to hospital'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 (SARS-CoV-2)', 'Homecare', 'Ambulatory'], 'conditions': ['Covid-19 (SARS-CoV-2)']}, 'descriptionModule': {'briefSummary': 'Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features', 'detailedDescription': "At the peak of the COVID-19 (SARS-CoV-2) pandemic in New York City, there was a shortage of hospital resources as well as a fear among many New Yorkers of going to the hospital. Emergency Services dead on arrival calls increased by as much as eight-fold.We created the CROWN Program, a pulmonary physician guided home-care protocol to treat ambulatory COVID-19 (SARS-CoV-2) patients with moderate to high risk features. This is a retrospective review of our CROWN program's patient characteristics, results and outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General public', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 (SARS-CoV-2) infection Ambulatory\n\nExclusion Criteria:\n\n* Need for hospital admission'}, 'identificationModule': {'nctId': 'NCT04476602', 'acronym': 'CROWN', 'briefTitle': 'Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol', 'orgStudyIdInfo': {'id': '20-0618'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 (SARS-CoV-2) patients', 'description': 'adults 18 or older, ambulatory , with COVID-19 (SARS-CoV-2)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': '410 Lakeville Road, Suite 107', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Gita Lisker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}, {'name': 'ramona ramdeo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Gita Lisker', 'investigatorAffiliation': 'Northwell Health'}}}}