Development of Interstitial Lung Disease (ILD) in Patients With Severe SARS-CoV-2 Infection (COVID-19)
NCT ID: NCT04416100
Last Updated: 2020-12-02
Study Results
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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UNKNOWN
130 participants
OBSERVATIONAL
2020-04-29
2022-04-28
Brief Summary
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Given the phylogenetic relationship between SARS-CoV-1 and SARS-CoV-2, the similar clinical course in severe cases and overlapping CT patterns in the acute setting, persistent radiological and pulmonary functional changes in survivors are conceivable. It is also conceivable that a proportion of survivors will develop progressive ILD, either due to viral or ventilator-induced alveolar damage, or both.
Here, the investigators intend to investigate COVID-19 survivors through clinical examinations, functional lung examinations, HR-CT scans, and by determining the "immunofibrotic" pattern in peripheral mononuclear cells (PBMCs) 1, 3, and 6 months after discharge.
Detailed Description
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In the SARS-CoV-1 outbreak of 2003, clinical course was characterized by fever, myalgia and other systemic symptoms, which generally improved after a few days, followed by a second phase with recurrence of fever, oxygen saturation and imaging progression of pneumonia, similar to that experienced by severely affected patients in the current pandemic. Importantly, a significant number of patients infected with SARS-CoV-1 suffered acute respiratory failure (ARDS) requiring invasive ventilatory support. The pulmonary pathology of fatal SARS cases was dominated by diffuse alveolar damage (DAD), epithelial cell proliferation, an increase in macrophages in the lung and extensive consolidation, but features of bronchiolitis obliterans and organizing pneumonia were also noted. In addition, survivors of severe SARS-CoV-1 infection showed significant functional and radiological changes in the lungs even 6 months after infection.
In the current SARS-CoV-2 pandemic, the most common computed tomographic changes in acute lung injury include bilateral and subpleural milk glass opacity, consolidation in lower lobes, or both. In the intermediate phase of the infection (4-14 days after the onset of symptoms) a so-called "crazy paving" may occur. The most prominent radiological changes occur around day 10, followed by gradual resolution, which begins two weeks after the onset of symptoms.
Given the phylogenetic relationship between SARS-CoV-1 and SARS-CoV-2, the similar clinical course in severe cases and overlapping CT patterns in the acute setting, persistent radiological and pulmonary functional changes in survivors are conceivable. It is also conceivable that a proportion of survivors will develop progressive ILD, either due to viral or ventilator-induced alveolar damage, or both.
Here, the investigators intend to investigate COVID-19 survivors through clinical examinations, functional lung examinations, HR-CT scans, and by determining the "immunofibrotic" pattern in peripheral mononuclear cells (PBMCs) 1, 3, and 6 months after discharge.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Pulmonary function tests
Spirometry or plethysmography, measurement of diffusion capacity
Imaging
HRCT and echocardiography as scheduled within routine clinical examinations
Blood sampling
Standard laboratory test as part of routine clinical examination and collection of peripheral blood for immunofibrotic phenotyping
Eligibility Criteria
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Inclusion Criteria
* Confirmed infection with SARS-CoV-2 according to the definition of the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection
* Signed and dated declaration of consent by the patient according to ICH-GCP Guidelines.
Exclusion Criteria
* Pregnancy
* Dementia
* Declaration of consent by the patient according to ICH-GCP Guidelines not signed
* Incapacitated patients
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Medical University Innsbruck
OTHER
Responsible Party
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Principal Investigators
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Ivan Tancevski, Doz. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University Innsbruck, Department Internal Medicine II
Locations
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Medical University of Innsbruck
Innsbruck, , Austria
Countries
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Central Contacts
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Facility Contacts
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Judith Löffler-Ragg, Prof. Dr.
Role: primary
References
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Rass V, Tymoszuk P, Sahanic S, Heim B, Ausserhofer D, Lindner A, Kofler M, Mahlknecht P, Boehm A, Hufner K, Pizzini A, Sonnweber T, Kurz K, Pfeifer B, Kiechl S, Peball M, Kindl P, Putnina L, Fava E, Djamshidian A, Huber A, Wiedermann CJ, Sperner-Unterweger B, Woll E, Beer R, Schiefecker AJ, Bellmann-Weiler R, Bachler H, Tancevski I, Pfausler B, Piccoliori G, Seppi K, Weiss G, Loffler-Ragg J, Helbok R. Distinct smell and taste disorder phenotype of post-acute COVID-19 sequelae. Eur Arch Otorhinolaryngol. 2023 Nov;280(11):5115-5128. doi: 10.1007/s00405-023-08163-x. Epub 2023 Sep 5.
Hufner K, Tymoszuk P, Sahanic S, Luger A, Boehm A, Pizzini A, Schwabl C, Koppelstatter S, Kurz K, Asshoff M, Mosheimer-Feistritzer B, Pfeifer B, Rass V, Schroll A, Iglseder S, Egger A, Woll E, Weiss G, Helbok R, Widmann G, Sonnweber T, Tancevski I, Sperner-Unterweger B, Loffler-Ragg J. Persistent somatic symptoms are key to individual illness perception at one year after COVID-19 in a cross-sectional analysis of a prospective cohort study. J Psychosom Res. 2023 Jun;169:111234. doi: 10.1016/j.jpsychores.2023.111234. Epub 2023 Mar 17.
Nagele F, Graber M, Hirsch J, Polzl L, Sahanic S, Fiegl M, Hau D, Engler C, Lechner S, Stalder AK, Mertz KD, Haslbauer JD, Tzankov A, Grimm M, Tancevski I, Holfeld J, Gollmann-Tepekoylu C. Correlation between structural heart disease and cardiac SARS-CoV-2 manifestations. Commun Med (Lond). 2022 Nov 11;2(1):142. doi: 10.1038/s43856-022-00204-6.
Sviridenko A, Boehm A, di Santo G, Uprimny C, Nilica B, Fritz J, Giesel FL, Haberkorn U, Sahanic S, Decristoforo C, Tancevski I, Widmann G, Loeffler-Ragg J, Virgolini I. Enhancing Clinical Diagnosis for Patients With Persistent Pulmonary Abnormalities After COVID-19 Infection: The Potential Benefit of 68 Ga-FAPI PET/CT. Clin Nucl Med. 2022 Dec 1;47(12):1026-1029. doi: 10.1097/RLU.0000000000004437. Epub 2022 Oct 15.
Sonnweber T, Tymoszuk P, Sahanic S, Boehm A, Pizzini A, Luger A, Schwabl C, Nairz M, Grubwieser P, Kurz K, Koppelstatter S, Aichner M, Puchner B, Egger A, Hoermann G, Woll E, Weiss G, Widmann G, Tancevski I, Loffler-Ragg J. Investigating phenotypes of pulmonary COVID-19 recovery: A longitudinal observational prospective multicenter trial. Elife. 2022 Feb 8;11:e72500. doi: 10.7554/eLife.72500.
Sonnweber T, Sahanic S, Pizzini A, Luger A, Schwabl C, Sonnweber B, Kurz K, Koppelstatter S, Haschka D, Petzer V, Boehm A, Aichner M, Tymoszuk P, Lener D, Theurl M, Lorsbach-Kohler A, Tancevski A, Schapfl A, Schaber M, Hilbe R, Nairz M, Puchner B, Huttenberger D, Tschurtschenthaler C, Asshoff M, Peer A, Hartig F, Bellmann R, Joannidis M, Gollmann-Tepekoylu C, Holfeld J, Feuchtner G, Egger A, Hoermann G, Schroll A, Fritsche G, Wildner S, Bellmann-Weiler R, Kirchmair R, Helbok R, Prosch H, Rieder D, Trajanoski Z, Kronenberg F, Woll E, Weiss G, Widmann G, Loffler-Ragg J, Tancevski I. Cardiopulmonary recovery after COVID-19: an observational prospective multicentre trial. Eur Respir J. 2021 Apr 29;57(4):2003481. doi: 10.1183/13993003.03481-2020. Print 2021 Apr.
Sonnweber T, Boehm A, Sahanic S, Pizzini A, Aichner M, Sonnweber B, Kurz K, Koppelstatter S, Haschka D, Petzer V, Hilbe R, Theurl M, Lehner D, Nairz M, Puchner B, Luger A, Schwabl C, Bellmann-Weiler R, Woll E, Widmann G, Tancevski I, Judith-Loffler-Ragg, Weiss G. Persisting alterations of iron homeostasis in COVID-19 are associated with non-resolving lung pathologies and poor patients' performance: a prospective observational cohort study. Respir Res. 2020 Oct 21;21(1):276. doi: 10.1186/s12931-020-01546-2.
Other Identifiers
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20200429-2255
Identifier Type: -
Identifier Source: org_study_id