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

• Conditions: Sars-CoV-2 Infection; COVID-19 Pneumonia

• 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

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