COVID-19 Infection and Epithelial Cell Markers

• Conditions: Covid19; Asthma

• Registration Number: NCT04787588
• Lead Sponsor: McMaster University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-14
• Status Verified: 2021-03
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08
• Primary Completion: 2021-12-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 235

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TSLP expression in nasal epithelium	Through study completion, an average of 1 year	Compare the level of TSLP expression in nasal epithelium in patients with and without COVID-19 infection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

McMaster Cardio-Respiratory Research Lab; 🇨🇦 Hamilton, Ontario, Canada