COVID-19 Infection and Epithelial Cell Markers

Asthma Clinical Trial

Official title:

COVID-19 Infection and Epithelial Cell Markers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04787588
• Other study ID #: 11033-T
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Covid19
• Infection

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