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

Covid19 Clinical Trial

— PROLUN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04535154
• Other study ID #: PROLUN
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Covid19
• Lung Function Decreased

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