Covid19PROLUNNCT04535154
Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19
An observational study of Covid19 and Lung Function Decreased, run by University Hospital, Akershus at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Lung Function Decreased
- How many people
- 264 participants
- Where
- 1 siteNorway
- Study dates
- 31 Mar 2020to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients hospitalized who have been hospitalized for COVID-19
Who may be able to join
- Discharged before June 1 2020 after hospitalization at participating hospital for COVID-19
Who cannot join
- Age < 18 years
- Dementia
- Living outside hospital catchment area
- Participation in WHO COVID-19 clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Covid19, Lung Function Decreased
- Being tested
- No interventions
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity
L
Measured: 3 months
Forced vital capacity
L
Measured: 12 months
Gas diffusion capacity of carbon monoxide
mmol/kPa*min
Measured: 3 months
Gas diffusion capacity of carbon monoxide
mmol/kPa*min
Measured: 12 months
modified Medical Respiratory Council Dyspnea Scale
Unit
Measured: 6 weeks
modified Medical Respiratory Council Dyspnea Scale
Unit
Measured: 3 months
modified Medical Respiratory Council Dyspnea Scale
Unit
Measured: 12 months
Parenchymal opacities of the lungs
Number of opacities in one lung zone
Measured: 3 months
Parenchymal opacities of the lungs
Number of opacities in one lung zone
Measured: 12 months
Secondary outcomes (6)
Forced expiratory capacity during 1st second of expiration
L
Measured: 3 months
Forced expiratory capacity during 1st second of expiration
L
Measured: 12 months
FEV1/FVC
Percentage
Measured: 3 months
FEV1/FVC
Percentage
Measured: 12 months
Gas diffusion capacity adjusted for alveolar ventilation (KCO)
mmol/kPa*min*L
Measured: 3 months
Gas diffusion capacity adjusted for alveolar ventilation (KCO)
mmol/kPa*min*L
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start31 Mar 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Ostfold Hospital Trust, Haukeland University Hospital, St. Olavs Hospital, The National Association for Heart and Lung Disease, Jessheim, Norway
- Responsible party
- Principal investigator, Gunnar Einvik, University Hospital, Akershus
- Investigators
- Gunnar Einvik, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535154
- Sponsor's protocol ID
- PROLUN
- Acronym
- PROLUN
- Status last verified
- Aug 2020
- First submitted
- 29 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35048715
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes and Lung Function After Hospitalization for COVID-19
- ClinicalTrials.gov ID
- NCT04535154
- Acronym / sponsor ID
- PROLUN / PROLUN
- Conditions
- Covid19, Lung Function Decreased
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Ostfold Hospital Trust, Haukeland University Hospital, St. Olavs Hospital, The National Association for Heart and Lung Disease, Jessheim, Norway
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients hospitalized who have been hospitalized for COVID-19
Key inclusion criteria (1 listed)
- Discharged before June 1 2020 after hospitalization at participating hospital for COVID-19
Key exclusion criteria (4 listed)
- Age < 18 years
- Dementia
- Living outside hospital catchment area
- Participation in WHO COVID-19 clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions | Other | – |
Primary outcome
Forced vital capacity
Time frame: 3 months
L
Forced vital capacity
Time frame: 12 months
L
Gas diffusion capacity of carbon monoxide
Time frame: 3 months
mmol/kPa*min
Gas diffusion capacity of carbon monoxide
Time frame: 12 months
mmol/kPa*min
modified Medical Respiratory Council Dyspnea Scale
Time frame: 6 weeks
Unit
modified Medical Respiratory Council Dyspnea Scale
Time frame: 3 months
Unit
modified Medical Respiratory Council Dyspnea Scale
Time frame: 12 months
Unit
Parenchymal opacities of the lungs
Time frame: 3 months
Number of opacities in one lung zone
Parenchymal opacities of the lungs
Time frame: 12 months
Number of opacities in one lung zone
6 secondary outcomes
Forced expiratory capacity during 1st second of expiration
Time frame: 3 months
Forced expiratory capacity during 1st second of expiration
Time frame: 12 months
FEV1/FVC
Time frame: 3 months
FEV1/FVC
Time frame: 12 months
Gas diffusion capacity adjusted for alveolar ventilation (KCO)
Time frame: 3 months
Gas diffusion capacity adjusted for alveolar ventilation (KCO)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Derived from this study: PubMed 35048715Ingul 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.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Einvik, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Lung Function Decreased, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04535154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.