COVID-19 Infection and Epithelial Cell Markers

Study Overview
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Brief Summary
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To assess if TSLP expression by airway epithelial cells following COVID-19 infection regulates viral load and disease severity.

Detailed Description
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The study aim is to determine the relationship between COVID-19 infection and epithelial cell expression of TSLP. Two cohorts will be used. Cohort One will include 100 hospitalized patients with Covid-19, and 100 hospitalized patients without Covid-19. Cohort 2 will include mild/moderate asthmatics and healthy controls with bio-banked biopsy material used from donors who have previously consented for samples to be used for future research.

Official Title
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COVID-19 Infection and Epithelial Cell Markers

Conditions
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Asthma, Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and above; Able to give informed consent; Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) and with a positive result and clinical features in keeping with COVID-19 illness. The control group will be patients with a negative RT-PCR COVID-19 test and without any clinical features to suggest COVID-19 illness. In addition, the control group should have NO known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer. Able to provide a breath sample (as based on clinical judgement). Exclusion Criteria: - none

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 |
| --- | --- |
| Hospitalized patients<br>100 patients hospitalized with Covid-19, and 100 hospitalized controls without Covid-19 | |
| Mild/Moderate asthma and health controls<br>20 asthmatic patients, 10 patients with asthma and allergic rhinitis, and 5 healthy controls. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSLP expression in nasal epithelium | Compare the level of TSLP expression in nasal epithelium in patients with and without COVID-19 infection | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSLP expression in endobronchial biopsies | Epithelial cell expression (protein staining) of TSLP in endobronchial biopsy tissue of asthmatic patients versus normal controls. | Baseline | 
| IL-33 expression in endobronchial biopsies | Epithelial cell expression (protein staining) of IL-33 in endobronchial biopsy tissue of asthmatic patients versus normal controls. | Baseline | 
| ACE-2 receptor expression in endobronchial biopsies | Epithelial cell expression (protein staining) of ACE-2 receptor in endobronchial biopsy tissue of asthmatic patients versus normal controls. | Baseline |