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

Sars-CoV-2 Infection Clinical Trial

— COREG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868864
• Other study ID #: 13161
• Status: Recruiting
• Start date: May 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: McMaster University
• Contact: Mylinh Duong, MD
• Phone: 905 525-9140
• Email: duongmy[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Radiological and lung function recovery following Covid-19 infection.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia
• Sars-CoV-2 Infection

Intervention

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

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Gilead Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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