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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Ostfold Hospital Trust | OTHER |
| Haukeland University Hospital | OTHER |
| St. Olavs Hospital |
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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).
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions | Other | No interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity | L | 3 months |
| Forced vital capacity | L | 12 months |
| Gas diffusion capacity of carbon monoxide | mmol/kPa*min | 3 months |
| Gas diffusion capacity of carbon monoxide | mmol/kPa*min | 12 months |
| modified Medical Respiratory Council Dyspnea Scale | Unit | 6 weeks |
| modified Medical Respiratory Council Dyspnea Scale | Unit | 3 months |
| modified Medical Respiratory Council Dyspnea Scale | Unit | 12 months |
| Parenchymal opacities of the lungs | Number of opacities in one lung zone | 3 months |
| Parenchymal opacities of the lungs | Number of opacities in one lung zone | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory capacity during 1st second of expiration | L | 3 months |
| Forced expiratory capacity during 1st second of expiration | L |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients hospitalized who have been hospitalized for COVID-19
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Einvik, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Pulmonary Medicine | Lørenskog | Akershus | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35048715 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2020 | Aug 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| OTHER |
| The National Association for Heart and Lung Disease, Jessheim, Norway | OTHER |
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| 12 months |
| FEV1/FVC | Percentage | 3 months |
| FEV1/FVC | Percentage | 12 months |
| Gas diffusion capacity adjusted for alveolar ventilation (KCO) | mmol/kPa*min*L | 3 months |
| Gas diffusion capacity adjusted for alveolar ventilation (KCO) | mmol/kPa*min*L | 12 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |