The Ontario Multi-Regional Hospital COVID-19 Registry (COREG)- Recovery Trajectory Sub-study

NCT ID: NCT04868864

Last Updated: 2021-05-25

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-12-31

Brief Summary

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Radiological and lung function recovery following Covid-19 infection.

Detailed Description

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The investigators propose to conduct pulmonary LDCT imaging and physiological lung function assessments, and combine this with detailed multi-regional hospitalization clinical data collection on COVID-19 cases (COREG registry); to inform long-term pulmonary and extra-pulmonary consequences and the recovery trajectory following COVID-19 infection.

Conditions

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COVID-19 Pneumonia Sars-CoV-2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate to severe COVID-19 infection

COVID-19 patients with radiographic changes on CXR or CT which had not resolved or had persistent hypoxia due to COVID-19 at the time of discharge will be enrolled. All participants will undergo a LDCT and PFT.

CT scan

Intervention Type DIAGNOSTIC_TEST

Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system

Pulmonary Function Test

Intervention Type DIAGNOSTIC_TEST

Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards

Persistent LDCT or PFT abnormalities

Participants with abnormalities on LDCT and or PFT will be invited to continue with a follow-up sub-study. This will involve follow up with repeated LDCT and PFT at subsequent time points to monitor and manage the abnormalities detected until the abnormalities fully resolve or to the last time point at 9 months of the study.

CT scan

Intervention Type DIAGNOSTIC_TEST

Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system

Pulmonary Function Test

Intervention Type DIAGNOSTIC_TEST

Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards

Interventions

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CT scan

Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system

Intervention Type DIAGNOSTIC_TEST

Pulmonary Function Test

Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients discharged from hospital post COVID-19 infection who have radiographic and clinical evidence of COVID-19 pneumonia during hospitalization.
* Patients with evidence of unresolved radiographic changes or persistent hypoxemia.

Exclusion Criteria

* Failure to comply with study procedures.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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MyLinh Duong

Professor Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mylinh Duong, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University Hospital

Locations

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Juravinski Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mylinh Duong, MD

Role: CONTACT

905 525-9140

Facility Contacts

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Mylinh Duong, MD PhD

Role: primary

Other Identifiers

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13161

Identifier Type: -

Identifier Source: org_study_id

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