Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-05 @ 6:31 PM
Study NCT ID:
NCT05042193
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 to Evaluate the Longevity of IgG Antibodies in Individuals Exposed to COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1883}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-19', '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': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2', 'timeFrame': 'Up to 9 months'}], 'secondaryOutcomes': [{'measure': 'To compare the off-kinetics of IgG positivity against SARS-CoV-2, stratified by age, sex, race, ethnicity, infection symptomaticity, initial viral load', 'timeFrame': 'Up to 9 months'}, {'measure': 'To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination', 'timeFrame': 'Up to 9 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2 Acute Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.', 'detailedDescription': 'This virtual clinical study will use a prospective design, to evaluate longevity and seroprevalence of IgG against SARS-CoV-2 in approximately 800 patients as measured by Dried Blood Spots via fingerstick using the Everlywell COVID-19 Antibody Test Home Collection Kit. Participants will be followed up to 9 months at 1, 3, 6 and 9 months after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who have tested positive for SARS-CoV-2 by either RT-PCR or Antigen test for COVID-19 or have received one of the commercially available SARS-CoV-2 vaccines.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing to provide informed consent prior to participation.\n* Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial\n* Cohort 2 (Arm 2) - Received the COVID-19 vaccine\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy'}, 'identificationModule': {'nctId': 'NCT05042193', 'briefTitle': 'A Prospective Virtual Study to Evaluate the Longevity of IgG Antibodies in Individuals Exposed to COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Everly Health'}, 'officialTitle': 'A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co', 'orgStudyIdInfo': {'id': 'EW-US-4010-0007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unvaccinated SARS-CoV-2 positive', 'description': 'Participants who have tested positive for SARS-CoV-2, both with and without symptoms, who have not been vaccinated', 'interventionNames': ['Other: SARS-CoV-2']}, {'label': 'Vaccinated', 'description': 'Participants who were vaccinated against SARS-CoV-2', 'interventionNames': ['Other: SARS-CoV-2']}], 'interventions': [{'name': 'SARS-CoV-2', 'type': 'OTHER', 'description': 'Observational', 'armGroupLabels': ['Unvaccinated SARS-CoV-2 positive', 'Vaccinated']}]}, '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'}}}}