Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT04868864

Conditions

COVID-19 Pneumonia

Sars-CoV-2 Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CT scan

Pulmonary Function Test

Study Details

Brief summary:

Radiological and lung function recovery following Covid-19 infection.

Conditions

COVID-19 Pneumonia

Sars-CoV-2 Infection

Study ID

NCT04868864

Start date

May 15, 2021

Status verified date

May, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Pulmonary changes on LDCT Scan [ Time Frame: Through study completion, an average of 9 months ]

Central Contacts and Locations

Central contacts

Mylinh Duong, MD

905 525-9140duongmy@mcmaster.ca

Locations

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

May 25, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-05-25.