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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04535154
Other study ID # PROLUN
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 31, 2020
Est. completion date June 1, 2022

Study information

Verified date August 2020
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 264
Est. completion date June 1, 2022
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No interventions
No interventions

Locations

Country Name City State
Norway Dept Pulmonary Medicine Lørenskog Viken

Sponsors (6)

Lead Sponsor Collaborator
University Hospital, Akershus Haukeland University Hospital, Oslo University Hospital, Ostfold Hospital Trust, St. Olavs Hospital, The National Association for Heart and Lung Disease, Jessheim, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forced vital capacity L 3 months
Primary Forced vital capacity L 12 months
Primary Gas diffusion capacity of carbon monoxide mmol/kPa*min 3 months
Primary Gas diffusion capacity of carbon monoxide mmol/kPa*min 12 months
Primary modified Medical Respiratory Council Dyspnea Scale Unit 6 weeks
Primary modified Medical Respiratory Council Dyspnea Scale Unit 3 months
Primary modified Medical Respiratory Council Dyspnea Scale Unit 12 months
Primary Parenchymal opacities of the lungs Number of opacities in one lung zone 3 months
Primary Parenchymal opacities of the lungs Number of opacities in one lung zone 12 months
Secondary Forced expiratory capacity during 1st second of expiration L 3 months
Secondary Forced expiratory capacity during 1st second of expiration L 12 months
Secondary FEV1/FVC Percentage 3 months
Secondary FEV1/FVC Percentage 12 months
Secondary Gas diffusion capacity adjusted for alveolar ventilation (KCO) mmol/kPa*min*L 3 months
Secondary Gas diffusion capacity adjusted for alveolar ventilation (KCO) mmol/kPa*min*L 12 months
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