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

SARS-CoV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750356
• Other study ID #: UCLH 134617
• Status: Recruiting
• Start date: January 27, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: University College, London
• Contact: Charles Swanton
• Phone: 020 3796 0000
• Email: crick-legacy[@]crick.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Disease Susceptibility
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
United Kingdom	Ealing and Northwick Park hospital	London
United Kingdom	The Francis Crick Institute	London
United Kingdom	UCLH	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	The Francis Crick Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	SARS-CoV-2 severity in healthcare workers and patients	To investigate SARS-CoV-2 severity by review of symptom severity	24 months
Primary	SARS-CoV-2 severity in healthcare workers and patients	To investigate SARS-CoV-2 severity by review of any hospital admissions	24 months