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

NCT ID: NCT04535154

Last Updated: 2020-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Covid19 Lung Function Decreased

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No interventions

No interventions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

The National Association for Heart and Lung Disease, Jessheim, Norway

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Gunnar Einvik

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Einvik, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

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Dept Pulmonary Medicine

Lørenskog, Akershus, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35048715 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PROLUN

Identifier Type: -

Identifier Source: org_study_id

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