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

• Conditions: Covid19; Lung Function Decreased

• Registration Number: NCT04535154
• Lead Sponsor: University Hospital, Akershus

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.

Study Timeline

• Study Start: 2020-03-31
• Status Verified: 2020-08
• Study First Submitted: 2020-08-29
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study First Posted: 2020-09-01
• Last Update Posted: 2020-09-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parenchymal opacities of the lungs	12 months	Number of opacities in one lung zone
Gas diffusion capacity of carbon monoxide	12 months	mmol/kPa\*min
Forced vital capacity	12 months	L
modified Medical Respiratory Council Dyspnea Scale	12 months	Unit

Secondary Outcome Measures

Name	Time	Method
Forced expiratory capacity during 1st second of expiration	12 months	L
Gas diffusion capacity adjusted for alveolar ventilation (KCO)	12 months	mmol/kPa\*min\*L
FEV1/FVC	12 months	Percentage

Trial Locations

Locations (1)

Dept Pulmonary Medicine; 🇳🇴 Lørenskog, Viken, Norway