COVID-19 Infection and Epithelial Cell Markers

NCT04787588 | Unknown

• 1 other identifier: 11033-T
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• TSLP expression in endobronchial biopsies

  Baseline

• IL-33 expression in endobronchial biopsies

  Baseline

• ACE-2 receptor expression in endobronchial biopsies

  Baseline

Study Arms (2)

Hospitalized patients

100 patients hospitalized with Covid-19, and 100 hospitalized controls without Covid-19

Mild/Moderate asthma and health controls

20 asthmatic patients, 10 patients with asthma and allergic rhinitis, and 5 healthy controls.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients

You may qualify if:

• 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).

You may not qualify if:

• \- none

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Cardio-Respiratory Research Lab

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood TSLP levels will be measured and SNP genotyping for alarmins will be performed from Cohort 1 patients

MeSH Terms

Conditions

Asthma; COVID-19

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Gail Gauvreau, PhD

  McMaster University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail Gauvreau, PhD

CONTACT

9055259140; gauvreau@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of MEdicine

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 8, 2021
• Study Start: February 14, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

CA (1)