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

May 20, 2022 updated by: University College, London

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • UCLH
        • Contact:
          • B Williams
      • London, United Kingdom
        • Recruiting
        • Ealing and Northwick Park hospital
        • Contact:
          • S. Quaid
        • Principal Investigator:
          • P. Papineni
      • London, United Kingdom
        • Recruiting
        • The Francis Crick Institute
        • Contact:
          • C Swanton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals who have previously provided samples for SARS-CoV-2 testing at the Crick COVID 19 Consortium Testing centre

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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
24 months
SARS-CoV-2 severity in healthcare workers and patients
Time Frame: 24 months
To investigate SARS-CoV-2 severity by review of symptom severity
24 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Francis Crick Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCLH 134617

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SARS-CoV Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe