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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04787588
Other study ID # 11033-T
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2021
Est. completion date February 1, 2022

Study information

Verified date March 2021
Source McMaster University
Contact Gail Gauvreau, PhD
Phone 9055259140
Email gauvreau@mcmaster.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 235
Est. completion date February 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Canada McMaster Cardio-Respiratory Research Lab Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 TSLP expression in endobronchial biopsies Epithelial cell expression (protein staining) of TSLP in endobronchial biopsy tissue of asthmatic patients versus normal controls. Baseline
Secondary 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
Secondary 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
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