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NCT04868864 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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