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

Sponsor
University College, London (Other)
Overall Status
Recruiting
CT.gov ID
NCT04750356
Collaborator
The Francis Crick Institute (Other)
6,000
Enrollment
3
Locations
47.1
Anticipated Duration (Months)
2000
Patients Per Site
42.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    SARS-CoV-2 Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity
    Actual Study Start Date :
    Jan 27, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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
    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.
    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.
    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.

    Outcome Measures

    Primary Outcome Measures

    1. SARS-CoV-2 susceptibility in healthcare workers and patients [24 months]

      To investigate SARS-CoV-2 susceptibility by examining the number of positive SARS-CoV-2 result per participant

    2. SARS-CoV-2 transmission in healthcare workers and patients [24 months]

      To investigate SARS-CoV-2 transmission by analysis of samples sequencing data from each study centre and across study centres

    3. SARS-CoV-2 severity in healthcare workers and patients [24 months]

      To investigate SARS-CoV-2 severity by review of symptom severity

    4. SARS-CoV-2 severity in healthcare workers and patients [24 months]

      To investigate SARS-CoV-2 severity by review of any hospital admissions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ealing and Northwick Park hospital London United Kingdom
    2 The Francis Crick Institute London United Kingdom
    3 UCLH London United Kingdom

    Sponsors and Collaborators

    • University College, London
    • The Francis Crick Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT04750356
    Other Study ID Numbers:
    • UCLH 134617
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Severe Acute Respiratory Syndrome
    Disease Susceptibility

    Study Results

    No Results Posted as of May 23, 2022