Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-26 @ 6:49 PM
Study NCT ID:
NCT04832932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2021-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D000069451', 'term': 'Long Term Adverse Effects'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D000090982', 'term': 'BNT162 Vaccine'}, {'id': 'D000090983', 'term': '2019-nCoV Vaccine mRNA-1273'}, {'id': 'D000090984', 'term': 'Ad26COVS1'}, {'id': 'D000090985', 'term': 'ChAdOx1 nCoV-19'}, {'id': 'C000722216', 'term': 'sinovac COVID-19 vaccine'}, {'id': 'C000722768', 'term': 'BIBP COVID-19 vaccine'}, {'id': 'C000722386', 'term': 'BBV152 COVID-19 vaccine'}, {'id': 'C000711928', 'term': 'NVX-CoV2373 adjuvated lipid nanoparticle'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D019444', 'term': 'Vaccines, DNA'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-01-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2021-04-02', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse reactions/events', 'timeFrame': '10 days after any dose of study intervention.', 'description': 'Percentage of occurrence, types, duration and severity of adverse events occurring within 10 days post-doses 1 and 2'}], 'secondaryOutcomes': [{'measure': 'Long-term adverse events', 'timeFrame': 'Throughout the study period, until 12 months post-final-dose', 'description': 'Percentage of occurrence, types, duration and severity of adverse events throughout study period'}, {'measure': 'Incidence of COVID-19 cases', 'timeFrame': 'From 14 days after completion of the 2-dose regimen up to 12 months post-final-dose', 'description': 'The number of COVID-19 cases occurring \\<=14 or ≥ 15 days after any dose of study intervention.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-Related Side Effects and Adverse Reactions', 'Long-term adverse effects', 'Immunogenicity, Vaccine', 'COVID-19'], 'conditions': ['COVID-19 Vaccines']}, 'referencesModule': {'references': [{'pmid': '36309347', 'type': 'RESULT', 'citation': 'Gabashvili IS. The Incidence and Effect of Adverse Events Due to COVID-19 Vaccines on Breakthrough Infections: Decentralized Observational Study With Underrepresented Groups. JMIR Form Res. 2022 Nov 4;6(11):e41914. doi: 10.2196/41914.'}], 'seeAlsoLinks': [{'url': 'https://www.aurametrix.com/nct04832932.html', 'label': 'Study updates'}]}, 'descriptionModule': {'briefSummary': 'During the study, members of different online and offline communities will be followed post COVID-19 vaccination.\n\nInjection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference.\n\nHypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.', 'detailedDescription': 'The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared a Public Health Emergency of International Concern in January 2020 and upgraded to pandemic in March 2020. First vaccines to prevent COVID-19 were authorized for emergency use in the US in December 2020, but a number of unknowns still remains. One of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. Study groups will be based on age, metabolism, donated diagnostic test results and self-reported symptoms. Data will be collected continuously via surveys and investigator-participant interactions, as needed. Statistical methods used will be the ones with the greatest power.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals 18 or older interested in vaccinating', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals 18 or older at the time of consent\n* Intention to vaccinate and of being available for entire study period\n\nExclusion Criteria:\n\n* Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.'}, 'identificationModule': {'nctId': 'NCT04832932', 'briefTitle': 'The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Mebo Research, Inc.'}, 'officialTitle': 'A Phenotypic Study of Safety, Tolerability, Reactogenicity, Immunogenicity, and Virus Shedding With Post-Vaccination Infections of Emergency-Use-Authorized Vaccines Against COVID-19', 'orgStudyIdInfo': {'id': '20210103MEBO'}}, 'armsInterventionsModule': {'armGroups': [{'label': '80 years of age or older', 'description': 'Individuals 80-89, 90-99, 100 years of age and older who received COVID-19 vaccine', 'interventionNames': ['Biological: COVID-19 vaccines']}, {'label': '60-79 years of age', 'description': 'Individuals 60-69 and 70-79 years of age who received COVID-19 vaccine', 'interventionNames': ['Biological: COVID-19 vaccines']}, {'label': '40-59 years of age', 'description': 'Individuals in 40-49, 50-59 age range who received COVID-19 vaccine', 'interventionNames': ['Biological: COVID-19 vaccines']}, {'label': '18-39 years of age', 'description': 'Individuals in 18-29, 30-39 age range who received COVID-19 vaccine', 'interventionNames': ['Biological: COVID-19 vaccines']}, {'label': 'MEBO/PATM', 'description': 'Individuals with present or past MEBO/PATM symptoms who received COVID-19 vaccine', 'interventionNames': ['Biological: COVID-19 vaccines']}, {'label': 'Chronic Disease', 'description': 'Individuals with self-reported chronic health conditions who received COVID-19 vaccine', 'interventionNames': ['Biological: COVID-19 vaccines']}], 'interventions': [{'name': 'COVID-19 vaccines', 'type': 'BIOLOGICAL', 'otherNames': ['BNT162b2', 'mRNA-1273', 'JNJ-78436735', 'AZD1222', 'Gam-KOVID-Vak', 'CoronaVac/Sinovac', 'BBIBP-CorV', 'BBV152', 'NVX-CoV2373'], 'description': 'Emergency-use authorized COVID-19 vaccines', 'armGroupLabels': ['18-39 years of age', '40-59 years of age', '60-79 years of age', '80 years of age or older', 'Chronic Disease', 'MEBO/PATM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'MEBO Research, Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '37885', 'city': 'Vonore', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Kahite', 'geoPoint': {'lat': 35.59008, 'lon': -84.24186}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Gabashvili', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '8 010', 'city': 'Kilifi', 'country': 'Kenya', 'facility': 'MEBO Research Africa', 'geoPoint': {'lat': -3.63045, 'lon': 39.84992}}, {'zip': 'W10 5LE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mebo Research (Uk)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Irene Gabashvili, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mebo Research, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data will remain confidential, unless specifically requested to be shared by the participant'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mebo Research, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aurametrix', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}