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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04535154

Acronym

PROLUN

Enrollment

264

Registered

2020-09-01

Start date

2020-03-31

Completion date

2022-06-01

Last updated

2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Lung Function Decreased

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.

Interventions

OTHERNo interventions

No interventions

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Forced vital capacity	3 months	L
Gas diffusion capacity of carbon monoxide	3 months	mmol/kPa\*min
modified Medical Respiratory Council Dyspnea Scale	6 weeks	Unit
Parenchymal opacities of the lungs	3 months	Number of opacities in one lung zone

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026