Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 11:15 AM
Study NCT ID:
NCT05042232
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Virtual Study of Patient Reported Behaviors and Health Outcomes in Individuals With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'To describe recovery in patients with test-confirmed COVID-19 infection including time to recovery and functional improvement', 'timeFrame': 'Up to 12 months'}, {'measure': 'To develop prediction tools for time to recovery, function and outcomes in patients with COVID-19 identified by home testing', 'timeFrame': 'Up to 12 months'}, {'measure': 'To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity', 'timeFrame': 'Up to 12 months'}, {'measure': 'To describe the feasibility of COVID-19 home testing', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2 Acute Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to identify and describe patient behaviors and clinical outcomes among patients who have tested positive for mild to moderate COVID-19.', 'detailedDescription': 'This virtual observational cohort study will describe patient behaviors and clinical outcomes of subjects who tested positive for COVID-19. Among those with positive tests, predictors of time to recovery, post-COVID function and outcomes will be identified. Individuals who test negative and positive for SARS-CoV-2 will be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who have valid COVID-19 test results.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years\n* Individuals with a valid diagnostic COVID-19 test result\n\nExclusion Criteria:\n\n\\- Unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05042232', 'briefTitle': 'A Prospective Virtual Study of Patient Reported Behaviors and Health Outcomes in Individuals With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Everly Health'}, 'officialTitle': 'Assessing Behavioral, Functional, and Clinical Patient-Reported Outcomes (PROs) in Subjects Diagnosed With COVID-19', 'orgStudyIdInfo': {'id': 'EW-US-4010-0003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SARS-CoV-2 Positive', 'type': 'OTHER', 'description': 'Participants who have tested positive for SARS-CoV-2, both with and without symptoms'}, {'name': 'SARS-CoV-2 Negative', 'type': 'OTHER', 'description': 'Participants who have tested negative for SARS-CoV-2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78703', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Everlywell, Inc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Timothy Bauer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Everly Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Everly Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}