COVID-19 PneumoniaCOREGNCT04868864
The Ontario Multi-Regional Hospital COVID-19 Registry (COREG)- Recovery Trajectory Sub-study
An observational study of COVID-19 Pneumonia and Sars-CoV-2 Infection, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Radiological and lung function recovery following Covid-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Sars-CoV-2 Infection
- What is being tested?
- CT scan and Pulmonary Function Test
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2021to 31 Dec 2022
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 patients discharged from hospitals with radiographic and clinical evidence of COVID-19 pneumonia during hospitalization.
Who may be able to join
- 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.
Who cannot join
- Failure to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Mylinh Duong, MD PhD
About this study
Radiological and lung function recovery following Covid-19 infection.
Read the 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.
- Conditions
- COVID-19 Pneumonia, Sars-CoV-2 Infection
- Being tested
- CT scan, Pulmonary Function Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system
Pulmonary Function TestDiagnostic test
Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards
| Study group | Role | What they receive |
|---|---|---|
| Moderate to severe COVID-19 infection | 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. Receives: Diagnostic Test: CT scan; Diagnostic Test: Pulmonary Function Test | |
| Persistent LDCT or PFT abnormalities | 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. Receives: Diagnostic Test: CT scan; Diagnostic Test: Pulmonary Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary changes on LDCT Scan
Identify pulmonary changes utilizing LDCT chest to characterize the pulmonary recovery trajectory of survivors of COVID-19.
Measured: Through study completion, an average of 9 months
Secondary outcomes (4)
DLCO
Identify DLCO changes over time to characterize the pulmonary recovery trajectory of survivors of COVID-19.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start15 May 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, MyLinh Duong, Hamilton Health Sciences Corporation
- Investigators
- Mylinh Duong, MD, Principal investigator, McMaster University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868864
- Sponsor's protocol ID
- 13161
- Acronym
- COREG
- Status last verified
- May 2021
- First submitted
- 24 Apr 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ontario Multi-Regional Hospital COVID-19 Registry (COREG)- Recovery Trajectory Sub-study
- ClinicalTrials.gov ID
- NCT04868864
- Acronym / sponsor ID
- COREG / 13161
- Conditions
- COVID-19 Pneumonia, Sars-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate to severe COVID-19 infection | – | Diagnostic Test: CT scan, Diagnostic Test: Pulmonary Function TestCOVID-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 | – | Diagnostic Test: CT scan, Diagnostic Test: Pulmonary Function TestParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients discharged from hospitals with radiographic and clinical evidence of COVID-19 pneumonia during hospitalization.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Failure to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanNon-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system | Diagnostic test | Moderate to severe COVID-19 infection, Persistent LDCT or PFT abnormalities |
| Pulmonary Function TestStandard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards | Diagnostic test | Moderate to severe COVID-19 infection, Persistent LDCT or PFT abnormalities |
Primary outcome
Pulmonary changes on LDCT Scan
Time frame: 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.
4 secondary outcomes
DLCO
Time frame: Through study completion, an average of 9 months
TLC
Time frame: Through study completion, an average of 9 months
FEV1
Time frame: Through study completion, an average of 9 months
FVC
Time frame: Through study completion, an average of 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mylinh Duong, MD principal investigator
McMaster University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Sars-CoV-2 Infection, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mylinh Duong, MD (905 525-9140, duongmy@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary changes on LDCT Scan (time frame: Through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.