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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535154
Recruitment Status : Active, not recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborators:
Oslo University Hospital
Ostfold Hospital Trust
Haukeland University Hospital
St. Olavs Hospital
The National Association for Heart and Lung Disease, Jessheim, Norway
Information provided by (Responsible Party):
Gunnar Einvik, 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).

Condition or disease Intervention/treatment
Covid19 Lung Function Decreased 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.

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Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No interventions
    No interventions


Primary Outcome Measures :
  1. Forced vital capacity [ Time Frame: 3 months ]
    L

  2. Forced vital capacity [ Time Frame: 12 months ]
    L

  3. Gas diffusion capacity of carbon monoxide [ Time Frame: 3 months ]
    mmol/kPa*min

  4. Gas diffusion capacity of carbon monoxide [ Time Frame: 12 months ]
    mmol/kPa*min

  5. modified Medical Respiratory Council Dyspnea Scale [ Time Frame: 6 weeks ]
    Unit

  6. modified Medical Respiratory Council Dyspnea Scale [ Time Frame: 3 months ]
    Unit

  7. modified Medical Respiratory Council Dyspnea Scale [ Time Frame: 12 months ]
    Unit

  8. Parenchymal opacities of the lungs [ Time Frame: 3 months ]
    Number of opacities in one lung zone

  9. Parenchymal opacities of the lungs [ Time Frame: 12 months ]
    Number of opacities in one lung zone


Secondary Outcome Measures :
  1. Forced expiratory capacity during 1st second of expiration [ Time Frame: 3 months ]
    L

  2. Forced expiratory capacity during 1st second of expiration [ Time Frame: 12 months ]
    L

  3. FEV1/FVC [ Time Frame: 3 months ]
    Percentage

  4. FEV1/FVC [ Time Frame: 12 months ]
    Percentage

  5. Gas diffusion capacity adjusted for alveolar ventilation (KCO) [ Time Frame: 3 months ]
    mmol/kPa*min*L

  6. Gas diffusion capacity adjusted for alveolar ventilation (KCO) [ Time Frame: 12 months ]
    mmol/kPa*min*L



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients hospitalized who have been hospitalized for COVID-19
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535154


Locations
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Norway
Dept Pulmonary Medicine
Lørenskog, Viken, Norway
Sponsors and Collaborators
University Hospital, Akershus
Oslo University Hospital
Ostfold Hospital Trust
Haukeland University Hospital
St. Olavs Hospital
The National Association for Heart and Lung Disease, Jessheim, Norway
Investigators
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Principal Investigator: Gunnar Einvik, PhD University Hospital, Akershus
  Study Documents (Full-Text)

Documents provided by Gunnar Einvik, University Hospital, Akershus:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gunnar Einvik, Primary Investigator, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04535154    
Other Study ID Numbers: PROLUN
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases