SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)

NCT ID: NCT04750356

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-27

Study Completion Date

2024-12-31

Brief Summary

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The study aims to investigate SARS-CoV-2 susceptibility, transmission and disease severity in healthcare workers and patients.

Residual 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

Detailed Description

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Conditions

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SARS-CoV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A1

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

No interventions assigned to this group

Cohort A2

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.

No interventions assigned to this group

Cohort B

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.

No interventions assigned to this group

Cohort C

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Individuals who have previously provided nasal throat swab samples for SARS-CoV-2 testing at the Crick COVID 19 Consortium Testing centre.
* ≥18 years of age
* To enrol in the SARS-CoV-2 positive cohort of the study, the participant should have a positive RT qPCR result
* Employees based at the participating sites including who had their serology and/or swab tested (for recruitment to Cohort B)
* Participants enrolled in other studies who had their samples processed by using the Crick COVID 19 Consortium Testing centre (for recruitment to Cohort C).
* Written informed consent (except Cohort A1)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Francis Crick Institute

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ealing and Northwick Park hospital

London, , United Kingdom

Site Status RECRUITING

The Francis Crick Institute

London, , United Kingdom

Site Status RECRUITING

UCLH

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Charles Swanton

Role: CONTACT

020 3796 0000

Facility Contacts

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S. Quaid

Role: primary

C Swanton

Role: primary

B Williams

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38512960 (View on PubMed)

Other Identifiers

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UCLH 134617

Identifier Type: -

Identifier Source: org_study_id

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