Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-25 @ 11:32 AM
Study NCT ID:
NCT06761612
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retail COVID-19 Study
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2660}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-31', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum S protein-specific binding antibody (bAb) concentrations (peak and exposure proximal assessments) Serum SARS-CoV-2 specific neutralizing antibody (nAb) titers (peak and exposure proximal assessments);', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)', 'description': 'Correlates of Protective Immunity'}, {'measure': 'Valid Viable specimens for SARS-CoV-2 testing', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5).', 'description': 'Number of viable specimens collected at retail pharmacies or retail clinics over the Day 366 follow-up period that meet quality standards required for laboratory analysis.'}, {'measure': 'Number of viable specimens for laboratory analysis', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)', 'description': 'Viable specimens collected at retail pharmacies or retail clinics that meet quality standards required for laboratory analysis.'}, {'measure': 'Number of valid specimens for CoP testing', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)', 'description': 'Valid specimens collected at retail pharmacies or retail clinics that meet quality standards required for CoP testing.'}], 'secondaryOutcomes': [{'measure': 'Representativeness of number of self-collected nasal swabs and blood specimens', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5). Various', 'description': 'Number of self-collected nasal swabs and blood specimens received over the Day 366 follow-up period overall and stratified by participant demographic and social determinants of health.'}, {'measure': 'Representativeness of Number of valid COVID-19 tests', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)', 'description': 'COVID-19 resulting in a positive or negative result for SARS-CoV-2 infection overall and stratified by participant demographic and social determinants of health.'}, {'measure': 'Assessment of participant recruitment speed', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)', 'description': 'Participant recruitment speed measured as time of vaccination to time of enrollment, overall and by site, as well as time to full enrollment overall and stratified by age.'}, {'measure': 'Assessment of participant retention', 'timeFrame': 'Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)', 'description': 'Participant retention over study period (from Day 1 through Day 366 follow-up) overall and stratified by age.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Vaccines', 'Correlates of Protective Immunity', 'Retail Pharmacy', 'Walgreens', 'Observational'], 'conditions': ['COVID - 19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.retailcovidstudy.com', 'label': 'Retail COVID-19 Study Website'}]}, 'descriptionModule': {'briefSummary': "Despite the availability of vaccines, there remains a need to identify specific immune responses that correlate with protection against SARS-CoV-2 infection. Additionally, the operational capability of retail pharmacy infrastructure to collect longitudinal data and biological samples needs to be assessed. This study aims to fill these gaps by determining correlates of protection (CoP), assessing the infrastructure's capability, and examining demographic and geographic differences in participation.", 'detailedDescription': "This multi-center study will utilize a prospective, longitudinal observational design to assess CoR and CoP for COVID-19 vaccinations. Prior to enrollment in this study, participants will receive a federally licensed and authorized vaccine, manufactured by Pfizer-BioNTech or Moderna, for the prevention of COVID-19. Each participant will complete a pre-screener questionnaire which will collect information to confirm the participant's eligibility. Upon passing the pre-screener, the participant will complete their electronic consent form and will be enrolled in the study within 72 hours of their vaccination with blood collected to establish baseline for humoral immune marker. A subset of total enrollment, a cohort of 80 participants, will also enroll in the PBMC cohort; participants in the PBMC cohort will enroll in the study within 24 hours of their vaccination with blood collected to establish baseline immune marker levels.\n\nDuring this study, participants will complete five (5) visits on site (Day 01, Day 31, Day 91, Day 181, Day 366), which will involve data collection and a blood draw. Participants enrolled in the PBMC cohort will have an additional blood draw at Day 01, Day 31, Day 181, and Day 366.\n\nAll study participants will complete a weekly electronic patient reported outcome (ePRO) to report symptoms of COVID-19, and to report if they have been exposed to anyone who has tested positive for COVID-19.\n\nParticipants will be asked to report to the clinic for a nasal swab test (via molecular assay) when: participant has at least one symptom with or without a fever, and/or if the participant has recent exposure or close contact to another person with COVID-19.\n\nThis study aims to enroll at least 90 COVID-19 endpoint cases, based on an annual incidence rate of 2.5%."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Prior to enrollment in this study, participants will receive a federally licensed and authorized vaccine, manufactured by Pfizer-BioNTech or Moderna, for the prevention of COVID-19. Each participant will complete a pre-screener questionnaire which will collect information to confirm the participant's eligibility. Upon passing the pre-screener, the participant will complete their electronic consent form and will be enrolled in the study within 72 hours of their vaccination with blood collected to establish baseline for humoral immune marker. A subset of total enrollment, a cohort of 80 participants, will also enroll in the PBMC cohort; participants in the PBMC cohort will enroll in the study within 24 hours of their vaccination with blood collected to establish baseline immune marker levels.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. People ≥3 years of age at time of enrollment.\n2. Willing and able to provide informed consent, or assent in pediatric population, if appropriate, prior to initiation of study procedures.\n3. Able to understand and comply with planned study procedures.\n4. Available for all study data collection points.\n5. Receipt of the most recent FDA-licensed and authorized COVID-19 vaccine (i.e., the 2024-2025 Moderna COVID-19 vaccine or the 2024-2025 Pfizer-BioNTech COVID-19 vaccine which includes the KP.2 strain of the JN.1-lineage vaccine), as recommended by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) and outlined in the FDA's updated guidance, administered within 3 days of enrollment.\n\nPBMC cohort only:\n\nPeople ages ≥18 years at time of enrollment. Available for first blood sample collection within 1 day of vaccine.\n\nExclusion Criteria:\n\n1. Currently participating or plans to participate in another clinical trial involving an investigational product before completing this study.\n2. Planned to receive another COVID-19 vaccine within 180 days.\n3. Receipt of COVID-19 vaccination within 180 days prior to current vaccination.\n4. Receipt of Shingrix vaccine in the 28 days prior to the COVID-19 vaccination or planned receipt of Shingrix vaccine within 28 days after receipt of COVID-19 vaccination.\n5. Self-report of recently confirmed COVID-19 infection within 30 days.\n6. Any disease or medical condition that, in the opinion of the principal investigator or sub-investigator, is a contraindication to study participation.\n\nPBMC cohort only:\n\nConfirmed positive urine pregnancy test at study visits per Schedule of Activities."}, 'identificationModule': {'nctId': 'NCT06761612', 'briefTitle': 'Retail COVID-19 Study', 'organization': {'class': 'FED', 'fullName': 'Biomedical Advanced Research and Development Authority'}, 'officialTitle': 'A Longitudinal Assessment of Serology and Effectiveness to Determine COVID-19 Vaccine Correlates of Risk (CoR) and Correlates of Protection (CoP) in a Heterogeneous US Population Through Use of Decentralized Sites and Approaches for Data/Specimen Collection', 'orgStudyIdInfo': {'id': 'RRPV-24-02-Retail-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Cohort', 'description': 'Cohort Provides blood draws during on-study visits', 'interventionNames': ['Biological: FDA approved mRNA vaccines']}, {'label': 'PBMC Cohort', 'description': 'Up to 80 participants providing PBMCs', 'interventionNames': ['Biological: FDA approved mRNA vaccines']}], 'interventions': [{'name': 'FDA approved mRNA vaccines', 'type': 'BIOLOGICAL', 'description': 'This study is non-interventional as participants will have received an FDA approved mRNA COVID-19 vaccine prior to entering the study. The study protocol does not determine or allocate receipt of vaccine', 'armGroupLabels': ['PBMC Cohort', 'Primary Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34746', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Walgreens - 3298 S John Young Pkwy', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '60615', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Walgreens - 1554 E 55th St', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60632', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Walgreens - 4385 S Archer Ave', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60302', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Walgreens - 811 Madison St', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'zip': '60305', 'city': 'River Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'Walgreens - 7251 Lake St', 'geoPoint': {'lat': 41.89781, 'lon': -87.81395}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Walgreens - 15100 W 87th Street Pkwy', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '66204', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Walgreens - 7500 Metcalf Ave', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '02148', 'city': 'Malden', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Walgreens - 215 Beach St', 'geoPoint': {'lat': 42.4251, 'lon': -71.06616}}, {'zip': '64056', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Walgreens - 17811 E US Highway 24', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Walgreens - 3845 Broadway Blvd', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64119', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Walgreens - 2630 NE Vivion', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89146', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Walgreens - 6401 W Charleston Blvd', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89032', 'city': 'North Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Walgreens - 1445 W Craig Rd', 'geoPoint': {'lat': 36.19886, 'lon': -115.1175}}, {'zip': '08401', 'city': 'Atlantic City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Walgreens - 3218 Atlantic Ave', 'geoPoint': {'lat': 39.36415, 'lon': -74.42306}}, {'zip': '08861', 'city': 'Perth Amboy', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Walgreens - 520 Convery Blvd', 'geoPoint': {'lat': 40.50677, 'lon': -74.26542}}, {'zip': '77301', 'city': 'Conroe', 'state': 'Texas', 'country': 'United States', 'facility': 'Walgreens - 420 N Frazier St', 'geoPoint': {'lat': 30.31188, 'lon': -95.45605}}, {'zip': '77019', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Walgreens - 1919 W Gray St', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77346', 'city': 'Humble', 'state': 'Texas', 'country': 'United States', 'facility': 'Walgreens - 7440 FM 1960 Rd E', 'geoPoint': {'lat': 29.99883, 'lon': -95.26216}}, {'zip': '77584', 'city': 'Pearland', 'state': 'Texas', 'country': 'United States', 'facility': 'Walgreens - 8430 Broadway St', 'geoPoint': {'lat': 29.56357, 'lon': -95.28605}}, {'zip': '77471', 'city': 'Rosenberg', 'state': 'Texas', 'country': 'United States', 'facility': 'Walgreens - 3316 Avenue H', 'geoPoint': {'lat': 29.55718, 'lon': -95.80856}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}