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

May 22, 2021 updated by: MyLinh Duong, Hamilton Health Sciences Corporation
Radiological and lung function recovery following Covid-19 infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Juravinski Hospital
        • Contact:
          • Mylinh Duong, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 patients discharged from hospitals with radiographic and clinical evidence of COVID-19 pneumonia during hospitalization.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: CT scan
Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system
Diagnostic test: Pulmonary Function 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.
Diagnostic test: CT scan
Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system
Diagnostic test: Pulmonary Function Test
Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary changes on LDCT Scan
Time Frame: Through study completion, an average of 9 months
Identify pulmonary changes utilizing LDCT chest to characterize the pulmonary recovery trajectory of survivors of COVID-19.
Through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLCO
Time Frame: Through study completion, an average of 9 months
Identify DLCO changes over time to characterize the pulmonary recovery trajectory of survivors of COVID-19.
Through study completion, an average of 9 months
TLC
Time Frame: Through study completion, an average of 9 months
Identify TLC changes over time to characterize the pulmonary recovery trajectory of survivors of COVID-19.
Through study completion, an average of 9 months
FEV1
Time Frame: Through study completion, an average of 9 months
Identify FEV1 changes over time to characterize the pulmonary recovery trajectory of survivors of COVID-19.
Through study completion, an average of 9 months
FVC
Time Frame: Through study completion, an average of 9 months
Identify FVC changes over time to characterize the pulmonary recovery trajectory of survivors of COVID-19.
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2021

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

April 24, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (ACTUAL)

May 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 22, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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