Clinical trial NCT04535154: Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19
Official title: Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lung Function Decreased
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Ostfold Hospital Trust
name: Haukeland University Hospital
name: St. Olavs Hospital
name: The National Association for Heart and Lung Disease, Jessheim, Norway
First posted: 2020-09-01
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients hospitalized who have been hospitalized for COVID-19

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced vital capacity
timeFrame: 3 months
measure: Forced vital capacity
timeFrame: 12 months
measure: Gas diffusion capacity of carbon monoxide
timeFrame: 3 months
measure: Gas diffusion capacity of carbon monoxide
timeFrame: 12 months
measure: modified Medical Respiratory Council Dyspnea Scale
timeFrame: 6 weeks
measure: modified Medical Respiratory Council Dyspnea Scale
timeFrame: 3 months
measure: modified Medical Respiratory Council Dyspnea Scale
timeFrame: 12 months
measure: Parenchymal opacities of the lungs
timeFrame: 3 months
measure: Parenchymal opacities of the lungs
timeFrame: 12 months
Secondary outcomes:
measure: Forced expiratory capacity during 1st second of expiration
timeFrame: 3 months
measure: Forced expiratory capacity during 1st second of expiration
timeFrame: 12 months
measure: FEV1/FVC
timeFrame: 3 months
measure: FEV1/FVC
timeFrame: 12 months
measure: Gas diffusion capacity adjusted for alveolar ventilation (KCO)
timeFrame: 3 months
measure: Gas diffusion capacity adjusted for alveolar ventilation (KCO)
timeFrame: 12 months
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Dept Pulmonary Medicine
state: Viken
Study officials:
affiliation: University Hospital, Akershus
name: Gunnar Einvik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.