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

Study Overview
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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.

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

Conditions
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COVID-19 Pneumonia, Sars-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: CT scan
* Diagnostic Test: Pulmonary Function Test


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate to severe COVID-19 infection<br>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<br>* Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system<br>Diagnostic Test: Pulmonary Function Test<br>* Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards<br>|
| Persistent LDCT or PFT abnormalities<br>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<br>* Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system<br>Diagnostic Test: Pulmonary Function Test<br>* Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards<br>|

What is the study measuring?
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Primary Outcome Measures

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