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

• Conditions: Sars-CoV-2 Infection; COVID-19 Pneumonia
• Interventions: Diagnostic Test: CT scan; Diagnostic Test: Pulmonary Function Test

• Registration Number: NCT04868864
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Radiological and lung function recovery following Covid-19 infection.

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 Timeline

• Study First Submitted: 2021-04-24
• Study First Submitted QC: 2021-04-27
• Status Verified: 2021-05
• Study First Posted: 2021-05-03
• Study Start: 2021-05-15
• Last Update Submitted: 2021-05-22
• Last Update Posted: 2021-05-25
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persistent LDCT or PFT abnormalities	CT scan	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.
Moderate to severe COVID-19 infection	CT scan	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.
Moderate to severe COVID-19 infection	Pulmonary Function Test	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.
Persistent LDCT or PFT abnormalities	Pulmonary Function Test	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.

Primary Outcome Measures

Name	Time	Method
Pulmonary changes on LDCT Scan	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada