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

Study Overview
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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

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

Conditions
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SARS-CoV Infection

Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A1<br>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<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 susceptibility in healthcare workers and patients | To investigate SARS-CoV-2 susceptibility by examining the number of positive SARS-CoV-2 result per participant | 24 months | 
| SARS-CoV-2 transmission in healthcare workers and patients | To investigate SARS-CoV-2 transmission by analysis of samples sequencing data from each study centre and across study centres | 24 months | 
| SARS-CoV-2 severity in healthcare workers and patients | To investigate SARS-CoV-2 severity by review of symptom severity | 24 months | 
| SARS-CoV-2 severity in healthcare workers and patients | To investigate SARS-CoV-2 severity by review of any hospital admissions | 24 months |