Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19

COVID-19 Clinical Trial

— COV2ICU-DK  

Official title:

Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354584
• Other study ID #: COV2ICU-DK
• Secondary ID: H-20023159R349-2
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: January 10, 2022

Study information

• Verified date: January 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.

Description:

The mechanisms of the ARDS-like respiratory failure observed in patients with COVID-19 are currently unknown, but may be related to a distinct local immune response within the lung. In the present study, we will examine the cellular and humoral pulmonary immune response in mechanically ventilated patients admitted to the ICU with COVID-19 by examining immune cell profiles, cytokine patterns, and the complement pathway in bronchoalveolar lavage fluid, and relate it to the concomitant systemic inflammatory response. We will examine the patients on day 1-3 and 7-9 after ICU admission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18y

• Mechanical ventilation

• Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)

• ARDS according to the Berlin definition

Exclusion Criteria:

• Untreated malignant tachycardia or bradycardia

• Suspected or verified intracranial hypertension (ICP > 15 mmHg)

• Unilateral lung ventilation

• Severe non-correctable coagulopathy

Related Conditions & MeSH terms

• COVID-19
• Inflammation
• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
Denmark	Dept. of Intensive Care 542, University Hospital Hvidovre	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	ICU mortality	Up to 6 months
Other	Mortality II	In hospital mortality	Up to 6 months
Other	Blood markers of inflammation	C-reactive protein, procalcitonin, ferritin	Daily assessment in the ICU up to 12 weeks
Other	Infiltrates on conventional chest x-ray	Number of participants with unilateral infiltrates or bilateral infiltrates and/or air bronchogram	Up to 12 weeks
Primary	White blood cell counts	Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood	Day 0 (subsequent to study inclusion in the ICU)
Primary	White blood cell counts	Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood	Day 7
Primary	Lymphocyte populations	Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood	Day 0 (subsequent to study inclusion in the ICU)
Primary	Lymphocyte populations	Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood	Day 7
Secondary	Cytokines	Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)	Day 0 (subsequent to study inclusion in the ICU)
Secondary	Cytokines	Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)	Day 7
Secondary	Lectin complement pathway	MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma	Day 0 (subsequent to study inclusion in the ICU)
Secondary	Lectin complement pathway	MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma	Day 7
Secondary	Microorganisms	Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)	Up to 12 weeks
Secondary	Respiratory pathogens	Respiratory filmarray PCR for testing for pathogens	Day 0 (subsequent to study inclusion in the ICU)
Secondary	Respiratory pathogens	Respiratory filmarray PCR for testing for pathogens	Day 7
Secondary	Ribosomal RNA in the airways	16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid	Day 0 (subsequent to study inclusion in the ICU)
Secondary	Ribosomal RNA in the airways	16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid	Day 7
Secondary	Levels of SARS-CoV-2 in the airways	Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid	Day 0 (subsequent to study inclusion in the ICU)
Secondary	Levels of SARS-CoV-2 in the airways	Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid	Day 7
Secondary	Surfactant in the airways	Measured in bronchoalveolar lavage fluid by fourier-transform infrared spectroscopy using the dipalmitoylphosphatidylcholine[DPPC]/spingomyelin[SM]) ratio	Day 0
Secondary	Autoantibodies against type I IFNs in the airways	Measured in bronchoalveolarlavage fluid	Day 0