Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19 (PROLUN)

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).

Study Overview

• Status: Unknown
• Conditions: Covid19; Lung Function Decreased
• Intervention / Treatment: Other: No interventions

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: Observational
• Enrollment (Actual): 264

Contacts and Locations

Study Locations

• Norway
  • Viken
    • Lørenskog, Viken, Norway
      • Dept Pulmonary Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients hospitalized who have been hospitalized for COVID-19

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced expiratory capacity during 1st second of expiration	L	3 months
Forced expiratory capacity during 1st second of expiration	L	12 months
FEV1/FVC	Percentage	3 months
FEV1/FVC	Percentage	12 months
Gas diffusion capacity adjusted for alveolar ventilation (KCO)	mmol/kPa*min*L	3 months
Gas diffusion capacity adjusted for alveolar ventilation (KCO)	mmol/kPa*min*L	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Oslo University Hospital; Ostfold Hospital Trust; Haukeland University Hospital; St. Olavs Hospital; The National Association for Heart and Lung Disease, Jessheim, Norway
• Investigators: Principal Investigator: Gunnar Einvik, PhD, University Hospital, Akershus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PROLUN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No