Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-04 @ 6:30 AM
Study NCT ID:
NCT04709068
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'study.team@currenthealth.com', 'phone': '617-208-4239', 'title': 'Clinical Research Lead', 'organization': 'Current Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'COVID19+', 'description': 'Current Health: wearable device and tablet used to collect health measures at home', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID19+', 'description': 'Current Health: wearable device and tablet used to collect health measures at home'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 30 days', 'description': 'a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COVID19+', 'description': 'Current Health: wearable device and tablet used to collect health measures at home'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'COVID19+', 'description': 'Current Health: wearable device and tablet used to collect health measures at home'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.6', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-11', 'size': 1206870, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-08-05T13:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'recruitment and enrollment challenges due to fast-changing landscape of pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2021-01-12', 'resultsFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-12', 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Compliance', 'timeFrame': 'up to 30 days', 'description': 'a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['wearable', 'at-home'], 'conditions': ['Covid19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://community.currenthealth.com/covid19-study', 'label': 'study information and eligibility for enrollment'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in the United States (contiguous states)\n* Aged 21 years or older\n* Able to provide documentation of +Polymerase Chain Reaction (PCR) or +antigen test for COVID-19 within the past 48 hours\n* Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily\n* Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up.\n\nExclusion Criteria:\n\n* Under the age of 21\n* Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19\n* Cannot confirm a PCR or antigen positive test for COVID-19\n* Is unable to read English\n* Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire\n* Is unwilling or unable to provide baseline data required for entry into the study\n* Is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up\n* Heavy tattooing on both upper arms\n* Known atrial fibrillation (permanent or paroxysmal)\n* Has taken/is taking part in a COVID-19 vaccine or treatment trial'}, 'identificationModule': {'nctId': 'NCT04709068', 'acronym': 'RiskSEARCH', 'briefTitle': 'Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Current Health'}, 'officialTitle': 'Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization', 'orgStudyIdInfo': {'id': 'Pro00047371'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID19+', 'interventionNames': ['Device: Current Health']}], 'interventions': [{'name': 'Current Health', 'type': 'DEVICE', 'description': 'wearable device and tablet used to collect health measures at home', 'armGroupLabels': ['COVID19+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Current Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Adam Wolfberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Current Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Current Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}