Characterisation of the Immune Response to SARS-CoV-2 / COVID-19

NCT04729452 | Completed

• 1 other identifier: CT 269506
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Emerging clinical details of the current SARS-CoV-2 pandemic have illustrated that there are multiple clinical presentations and outcomes of this viral infection. People with an infection have been reported to have a spectrum of disease from severe acute respiratory distress requiring ventilation, to mild respiratory or gastrointestinal symptoms and asymptomatic presentations. Mechanisms explaining the heterogeneity of host response to infection are yet to be characterised. The aim of this project is to understand the host immune response to infection with SARS-CoV-2 over time in convalescent adults, including acquired immune responses, circulating levels of immune signalling molecules, gene expression profiling in peripheral blood and to identify host genetic variants associated with disease progressions or severity. Participants will be healthcare workers who had a diagnosis of COVID-19 (confirmed by positive RT-PCR assay) more than 28 days ago and have recovered and are employed by Cwm Taf Morgannwg University health board. Samples will be processed and analysed to explore immunological, host genetic factors and virological factors that explain pathogenesis and predict outcomes of infection.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Determination of key protective cellular immune parameters

  Our primary objective is to determine key protective cellular immune parameters (e.g. T cell responses) and confirm whether there are host genetic factors that provide protection from disease. We aim to define immunodominant SARS-CoV-2 T-cell epitopes by screening overlapping peptides from the viral proteome and mapping responses to individual COVID proteins expressed intracellularly in antigen-presenting cells (to confirm processing and presentation at the cell surface). Peptide-HLA multimers will be constructed for confirmed immunodominant responses. These reagents will allow rapid enumeration and tracking of COVID-specific T cell responses in patient samples.

  2 years

Secondary Outcomes (1)

• Determination of public T-cell receptor response to SARS-CoV-2

  3 years

Interventions

blood test OTHER

blood test to test immune response to SARS-CoV-2

Also known as: serial blood tests over 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Health care workers who had a positive SARS-CoV-2 nasopharyngeal swab test more than 28 days before recruitment

You may qualify if:

• The study will enrol eligible participants with confirmed COVID-19 PCR-based test 28 or more days prior to recruitment and be convalescent. Participants must be 18 years old and must have the capacity to provide written consent after discussing the participant information sheet. Participants must be health care workers for Cwm Taf Morgannwg University Health board.

You may not qualify if:

• Participants who are acutely unwell with COVID. Participants who cannot provide informed written consent. Participants who have a clear co-infection with a relevant pathogen.

Sponsors & Collaborators

• Cwm Taf University Health Board (NHS): lead
• Cardiff University: collaborator
• University of Oxford: collaborator

Study Sites (1)

Cwm Taf Morgannwg University Health board

Llantrisant, Rhondda Cynon Taf, CF82 7XR, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Lecturer and Associate Specialist

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: June 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)