COVID-19 Infection and Epithelial Cell Markers

NCT ID: NCT04787588

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-14

Study Completion Date

2022-02-01

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.

Conditions

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Asthma Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hospitalized patients

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

No interventions assigned to this group

Mild/Moderate asthma and health controls

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

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Gail Gauvreau

Professor Department of MEdicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gail Gauvreau, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University Hospital

Locations

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McMaster Cardio-Respiratory Research Lab

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Gail Gauvreau, PhD

Role: CONTACT

9055259140 ext. 22791

Facility Contacts

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Gail Gauvreau, PhD

Role: primary

9055259140 ext. 22600

Role: backup

9055259140 ext. 22791

Other Identifiers

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11033-T

Identifier Type: -

Identifier Source: org_study_id

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