Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04416100
Status:
UNKNOWN
Last Update Posted:
2020-12-02
First Post:
2020-05-26
Brief Title:
Development of Interstitial Lung Disease ILD in Patients With Severe SARS-CoV-2 Infection COVID-19
Sponsor:
Medical University Innsbruck
Organization:
Medical University Innsbruck
Study Overview
Official Title:
Development of Interstitial Lung Disease ILD in Patients With Severe SARS-CoV-2 Infection
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CovILD
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 affectedThe 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
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:
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 05 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 andor 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 25 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 37000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None