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Clinical Trials/NCT04750356
NCT04750356RecruitingNot Applicable

SARS-CoV-2 Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity

University College, London3 sites in 1 country6,000 target enrollmentStarted: January 27, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
6,000
Locations
3
Primary Endpoint
SARS-CoV-2 susceptibility in healthcare workers and patients

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

SARS-CoV-2 susceptibility in healthcare workers and patients

Time Frame: 24 months

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

SARS-CoV-2 transmission in healthcare workers and patients

Time Frame: 24 months

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

SARS-CoV-2 severity in healthcare workers and patients

Time Frame: 24 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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