Development of Interstitial Lung Disease (ILD) in Patients With Severe SARS-CoV-2 Infection (COVID-19)

NCT04416100 | Unknown

• 1 other identifier: 20200429-2255
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19, the infectious disease caused by the novel coronavirus SARS-CoV-2, currently poses a global economic, social, political and medical challenge. The virus originated in December 2019 in Wuhan, China, and has spread rapidly around the world. Currently, European countries, including Austria, are severely affected.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

Covid-19; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (3)

• Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 1 month

  Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 1 month after discharge or diagnosis of COVID-19 disease by the use of HR-CT.

  1 month

• Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 3 months

  Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 3 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT

  3 months

• Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 6 months

  Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 6 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT

  6 months

Interventions

Pulmonary function tests DIAGNOSTIC_TEST

Spirometry or plethysmography, measurement of diffusion capacity

Imaging DIAGNOSTIC_TEST

HRCT and echocardiography as scheduled within routine clinical examinations

Blood sampling BIOLOGICAL

Standard laboratory test as part of routine clinical examination and collection of peripheral blood for immunofibrotic phenotyping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients discharged from hospital or outpatients referred to our Outpatient Department of Pneumology at the University Hospital of Innsbruck because of persistent respiratory symptoms in recovery phase will be followed up. Diagnosis of COVID-19 must have been ensured by nasopharyngeal and oropharyngeal swabs.

You may qualify if:

• Female and male patients ≥ 18 years.
• 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.

You may not qualify if:

• Female and male patients \< 18 years
• Pregnancy
• Dementia
• Declaration of consent by the patient according to ICH-GCP Guidelines not signed
• Incapacitated patients

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Medical University of Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Related Publications (7)

• 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.

  PMID: 37670171 DERIVED

• 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.

  PMID: 36965396 DERIVED

• 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.

  PMID: 36369278 DERIVED

• 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.

  PMID: 36257062 DERIVED

• 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.

  PMID: 35131031 DERIVED

• 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.

  PMID: 33303539 DERIVED

• 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.

  PMID: 33087116 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Collection of peripheral blood will be done in the context of a routine blood draw in all study participants (in addition for immunofibrotic phenotyping) at our study centre at indicated time-points.

MeSH Terms

Conditions

COVID-19; Pulmonary Fibrosis

Interventions

Respiratory Function Tests; Diagnostic Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ivan Tancevski, Doz. Dr.

  Medical University Innsbruck, Department Internal Medicine II

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Löffler-Ragg, Prof. Dr.

CONTACT

+43-512-504-81413; judith.loeffler@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: April 29, 2020
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: December 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)