Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19
PROLUN
1 other identifier
observational
264
1 country
1
Brief Summary
A multicenter prospective cohort study performed at 6 major teaching hospitals in Southern Norway to study patient reported outcomes, lung function and pulmonary CT in patients at 3 and 12 months after hospitalization for coronavirus disease 2019 (COVID-19).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2020
CompletedFirst Submitted
Initial submission to the registry
August 29, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedSeptember 1, 2020
August 1, 2020
1.2 years
August 29, 2020
August 31, 2020
Conditions
Outcome Measures
Primary Outcomes (9)
Forced vital capacity
L
3 months
Forced vital capacity
L
12 months
Gas diffusion capacity of carbon monoxide
mmol/kPa\*min
3 months
Gas diffusion capacity of carbon monoxide
mmol/kPa\*min
12 months
modified Medical Respiratory Council Dyspnea Scale
Unit
6 weeks
modified Medical Respiratory Council Dyspnea Scale
Unit
3 months
modified Medical Respiratory Council Dyspnea Scale
Unit
12 months
Parenchymal opacities of the lungs
Number of opacities in one lung zone
3 months
Parenchymal opacities of the lungs
Number of opacities in one lung zone
12 months
Secondary Outcomes (6)
Forced expiratory capacity during 1st second of expiration
3 months
Forced expiratory capacity during 1st second of expiration
12 months
FEV1/FVC
3 months
FEV1/FVC
12 months
Gas diffusion capacity adjusted for alveolar ventilation (KCO)
3 months
- +1 more secondary outcomes
Interventions
No interventions
Eligibility Criteria
Consecutive patients hospitalized who have been hospitalized for COVID-19
You may qualify if:
- Discharged before June 1 2020 after hospitalization at participating hospital for COVID-19
You may not qualify if:
- Age \< 18 years
- Dementia
- Living outside hospital catchment area
- Participation in WHO COVID-19 clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Akershuslead
- Oslo University Hospitalcollaborator
- Ostfold Hospital Trustcollaborator
- Haukeland University Hospitalcollaborator
- St. Olavs Hospitalcollaborator
- The National Association for Heart and Lung Disease, Jessheim, Norwaycollaborator
Study Sites (1)
Dept Pulmonary Medicine
Lørenskog, Akershus, Norway
Related Publications (1)
Ingul CB, Grimsmo J, Mecinaj A, Trebinjac D, Berger Nossen M, Andrup S, Grenne B, Dalen H, Einvik G, Stavem K, Follestad T, Josefsen T, Omland T, Jensen T. Cardiac Dysfunction and Arrhythmias 3 Months After Hospitalization for COVID-19. J Am Heart Assoc. 2022 Feb;11(3):e023473. doi: 10.1161/JAHA.121.023473. Epub 2022 Jan 20.
PMID: 35048715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunnar Einvik, PhD
University Hospital, Akershus
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
August 29, 2020
First Posted
September 1, 2020
Study Start
March 31, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2022
Last Updated
September 1, 2020
Record last verified: 2020-08