- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535154
Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19 (PROLUN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This cohort study aim to describe the Natural course of COVID-19 disease in an consecutive and unselected cohort of Norwegians that have been hospitalized.
In addition to the primary and secondary outcomes related to PROMS, lung function and pulmonary CT, the study also have several substudies: Cardiology: The study includes echocardiography, 24-h electrocardiography and cardiopulmonary exercise test.
ENT: The study includes CT of head sinuses and patient-reported sleep disturbances and nose symptoms in a subgroup of patients.
Laboratory: Analyses of common markers of inflammation and cardiac biomarkers.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Viken
-
Lørenskog, Viken, Norway
- Dept Pulmonary Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Discharged before June 1 2020 after hospitalization at participating hospital for COVID-19
Exclusion Criteria:
- Age < 18 years
- Dementia
- Living outside hospital catchment area
- Participation in WHO COVID-19 clinical trial
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced vital capacity
Time Frame: 3 months
|
L
|
3 months
|
Forced vital capacity
Time Frame: 12 months
|
L
|
12 months
|
Gas diffusion capacity of carbon monoxide
Time Frame: 3 months
|
mmol/kPa*min
|
3 months
|
Gas diffusion capacity of carbon monoxide
Time Frame: 12 months
|
mmol/kPa*min
|
12 months
|
modified Medical Respiratory Council Dyspnea Scale
Time Frame: 6 weeks
|
Unit
|
6 weeks
|
modified Medical Respiratory Council Dyspnea Scale
Time Frame: 3 months
|
Unit
|
3 months
|
modified Medical Respiratory Council Dyspnea Scale
Time Frame: 12 months
|
Unit
|
12 months
|
Parenchymal opacities of the lungs
Time Frame: 3 months
|
Number of opacities in one lung zone
|
3 months
|
Parenchymal opacities of the lungs
Time Frame: 12 months
|
Number of opacities in one lung zone
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced expiratory capacity during 1st second of expiration
Time Frame: 3 months
|
L
|
3 months
|
Forced expiratory capacity during 1st second of expiration
Time Frame: 12 months
|
L
|
12 months
|
FEV1/FVC
Time Frame: 3 months
|
Percentage
|
3 months
|
FEV1/FVC
Time Frame: 12 months
|
Percentage
|
12 months
|
Gas diffusion capacity adjusted for alveolar ventilation (KCO)
Time Frame: 3 months
|
mmol/kPa*min*L
|
3 months
|
Gas diffusion capacity adjusted for alveolar ventilation (KCO)
Time Frame: 12 months
|
mmol/kPa*min*L
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gunnar Einvik, PhD, University Hospital, Akershus
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROLUN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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