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

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ClinicalTrials.gov Identifier: NCT04416100
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

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.


Condition or disease Intervention/treatment
Covid-19 Pulmonary Fibrosis Diagnostic Test: Pulmonary function tests Diagnostic Test: Imaging Biological: Blood sampling

Detailed Description:

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. In January 2020, the World Health Organisation declared a "Public Health Event of International Concern" and since 11 March 2020 COVID-19 has been classified as a pandemic. Overall mortality rates vary widely, ranging from 0.5 to 7%. These highly depend on the stringency of the tests in a particular region and the age of the patients with higher mortality rates in older people. The majority of patients show only mild symptoms with fever and/or cough, and it is even believed that there is a significant proportion of untested asymptomatic carriers that can transmit the virus to other people. 26 to 33% of in-patients have been admitted to intensive care due to a severe lung disease. Of these, 2.5 to 10% required invasive mechanical ventilation and 15 to 22% of these patients died in hospital, indicating the potential risk to public health. As a result, the current global death toll from COVID-19 already exceeds 37,000 people on 31 March 2020.

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Interstitial Lung Disease (ILD) in Patients With Severe SARS-CoV-2 Infection
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : April 28, 2022
Estimated Study Completion Date : April 28, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Pulmonary function tests
    Spirometry or plethysmography, measurement of diffusion capacity
  • Diagnostic Test: Imaging
    HRCT and echocardiography as scheduled within routine clinical examinations
  • Biological: Blood sampling
    Standard laboratory test as part of routine clinical examination and collection of peripheral blood for immunofibrotic phenotyping


Primary Outcome Measures :
  1. Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 1 month [ Time Frame: 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.

  2. Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 3 months [ Time Frame: 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. Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 6 months [ Time Frame: 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


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.


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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
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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): NCT04416100


Contacts
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Contact: Judith Löffler-Ragg, Prof. Dr. +43-512-504-81413 judith.loeffler@i-med.ac.at

Locations
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Austria
Medical University of Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Judith Löffler-Ragg, Prof. Dr.         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Ivan Tancevski, Doz. Dr. Medical University Innsbruck, Department Internal Medicine II
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04416100    
Other Study ID Numbers: 20200429-2255
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases