COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
ALSPAC will complete a case selection process to identify participants who are likely to have had a SARS-CoV-2 infection and controls who are unlikely to have had COVID-19. This will involve review of
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants of the ALSPAC cohort meeting the following criteria: 1. Aged 25 or over 2. Undergone SARS-CoV-2 antibody testing through the ALSPAC SARS-CoV-2 serology study (IRAS 289493) 3. Individuals who, through self-report or through linkage to official health records, are identified as being highly likely to have had COVID-19 infection (from either positive SARS-CoV-2 PCR test performed at NHS care facility, COVID-19 testing site or home testing) 4. Individuals who have been told by a physician that, in the opinion of that doctor, they have had a clinical illness likely to be COVID-19 Control participants 5. Aged 25 or over 6. Individuals who self-report as not experiencing symptoms of COVID-19 via the symptom survey 7. Self-report as not having had positive SARS-CoV-2 molecular test 8. Are confirmed SARS-CoV-2 seronegative at Visit 1
Exclusion criteria
Exclusion criteria: Exclusion criteria for both controls and cases: 1. Do not wish to participate in this research study 2. Participants taking blood thinners or blood-thinning agents (e.g. warfarin) or with a known clotting disorder or other reason unable to provide a blood sample 3. Not willing to provide blood samples 4. Do not meet eligibility criteria for respective arm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Presence in saliva of SARS-CoV-2 determined using reverse transcriptase polymerase chain reaction (RT-PCR assay) at baseline, 4 months and 9 months 2. Titres (concentration) of each antibody isotype (e.g. IgM, IgA, IgG) in blood samples specific to SARS-CoV-2 viral proteins/epitopes being produced determined by ELISA and Western blots. At baseline, 4 months and 9 months 3. B and T-cell immune response and characteristics of innate immune cell function by laboratory analysis of blood samples (flow cytometry, ELISpots, ELISA) at baseline, 4 months and 9 months 4. Immune response to COVID-19 and cross-reactive immune responses against other pathogens such as the circulating human CoVs by laboratory analysis of blood samples (B-cell receptor (BCR) sequencing, T-cell receptor (TCR) sequencing, NanoString analysis, RNAseq, single cell analysis, transciptomics, proteomics, cell signalling analysis, analysis of cellular cytotoxicity) at baseline, 4 months and 9 months 5. T-Cell, B-cell and antibody cross-reactivity and definition of how cross-reactivity may influence response to infection and/or vaccination by laboratory analysis of blood samples (B-cell receptor (BCR) sequencing, T-cell receptor (TCR) sequencing, NanoString analysis, RNAseq, single cell analysis, transciptomics, proteomics, cell signalling analysis, analysis of cellular cytotoxicity) at baseline, 4 months and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Exercise capacity by the completion of sit to stand or 6 min walk tests and measurement of heart rate and oxygen saturation at baseline, 4 months and 9 months 2. Quality of life by the completion of the SF36 questionnaire at baseline, 4 months and 9 months 3. BMI by measurement of height and weight at baseline, 4 months and 9 months | — |
Countries
England, United Kingdom
Contacts
Public ContactLynn Molloy
Outcome results
None listed