Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT04750356
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2021-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blod samples and nasal and throat swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 susceptibility in healthcare workers and patients', 'timeFrame': '24 months', 'description': 'To investigate SARS-CoV-2 susceptibility by examining the number of positive SARS-CoV-2 result per participant'}, {'measure': 'SARS-CoV-2 transmission in healthcare workers and patients', 'timeFrame': '24 months', 'description': 'To investigate SARS-CoV-2 transmission by analysis of samples sequencing data from each study centre and across study centres'}, {'measure': 'SARS-CoV-2 severity in healthcare workers and patients', 'timeFrame': '24 months', 'description': 'To investigate SARS-CoV-2 severity by review of symptom severity'}, {'measure': 'SARS-CoV-2 severity in healthcare workers and patients', 'timeFrame': '24 months', 'description': 'To investigate SARS-CoV-2 severity by review of any hospital admissions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV Infection']}, 'referencesModule': {'references': [{'pmid': '38512960', 'type': 'DERIVED', 'citation': "Townsley H, Gahir J, Russell TW, Greenwood D, Carr EJ, Dyke M, Adams L, Miah M, Clayton B, Smith C, Miranda M, Mears HV, Bailey C, Black JRM, Fowler AS, Crawford M, Wilkinson K, Hutchinson M, Harvey R, O'Reilly N, Kelly G, Goldstone R, Beale R, Papineni P, Corrah T, Gilson R, Caidan S, Nicod J, Gamblin S, Kassiotis G, Libri V, Williams B, Gandhi S, Kucharski AJ, Swanton C, Bauer DLV, Wall EC. COVID-19 in non-hospitalised adults caused by either SARS-CoV-2 sub-variants Omicron BA.1, BA.2, BA.4/5 or Delta associates with similar illness duration, symptom severity and viral kinetics, irrespective of vaccination history. PLoS One. 2024 Mar 21;19(3):e0294897. doi: 10.1371/journal.pone.0294897. eCollection 2024."}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate SARS-CoV-2 susceptibility, transmission and disease severity in healthcare workers and patients.\n\nResidual specimens from an existing collection of samples in viral inactivating buffer and derivatives and serum from the Crick COVID-19 Consortium Testing centre (Cohort A1) and additional biological material collected prospectively (Cohorts A2 and B) will be used for research into SARS-CoV-2 transmission, evolution and immune control. This testing centre is a partnership between UCLH and The Francis Crick Institute to provide COVID 19 RT PCR testing for healthcare workers (HCWs) and patients in London Hospitals and care homes. A third group (Cohort C) of the study will allow for collaborative work with other REC approved research studies that have used the Crick COVID-19 Consortium Testing centre and will involve the use of study samples already collected from each study to be analysed under the SARS-CoV-2 Longitudinal Study end points'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who have previously provided samples for SARS-CoV-2 testing at the Crick COVID 19 Consortium Testing centre', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who have previously provided nasal throat swab samples for SARS-CoV-2 testing at the Crick COVID 19 Consortium Testing centre.\n* ≥18 years of age\n* To enrol in the SARS-CoV-2 positive cohort of the study, the participant should have a positive RT qPCR result\n* Employees based at the participating sites including who had their serology and/or swab tested (for recruitment to Cohort B)\n* Participants enrolled in other studies who had their samples processed by using the Crick COVID 19 Consortium Testing centre (for recruitment to Cohort C).\n* Written informed consent (except Cohort A1)'}, 'identificationModule': {'nctId': 'NCT04750356', 'briefTitle': 'SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'SARS-CoV-2 Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity', 'orgStudyIdInfo': {'id': 'UCLH 134617'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A1', 'description': 'Healthcare workers and patients that have previously undertaken a swab or serology test to detect for the presence of SARS-CoV-2. Without the need to seek retrospective consent for the SARS CoV 2 Longitudinal Study, residual samples and derivatives from the Crick COVID -9 Consortium Testing centre and data will be used for the study'}, {'label': 'Cohort A2', 'description': '3,000 SARS-CoV-2 positive and 3,000 SARS-CoV-2 negative participants (randomly selected) from cohort A1 will be prospectively consented to the study. In addition, vaccine status will also be used to stratify the participants and recruit to the study.'}, {'label': 'Cohort B', 'description': 'Employees at participating centres including but not limited to UCLH and The Francis Crick Institute who have their serology tested and/or are swabbed for viral (SARS-CoV-2 and seasonal viruses) detection as well as participants who are vaccinated will be prospectively consented to the study.'}, {'label': 'Cohort C', 'description': 'Individuals recruited to other REC approved research studies where their samples are processed by the Crick COVID 19 Consortium Testing centre will also be consented in their existing study to allow the use of leftover study samples already collected and to be collected, for use in this longitudinal study.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'S. Quaid', 'role': 'CONTACT'}, {'name': 'P. Papineni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ealing and Northwick Park hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'C Swanton', 'role': 'CONTACT'}], 'facility': 'The Francis Crick Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'B Williams', 'role': 'CONTACT'}], 'facility': 'UCLH', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Charles Swanton', 'role': 'CONTACT', 'email': 'crick-legacy@crick.ac.uk', 'phone': '020 3796 0000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Francis Crick Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}