Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19

Completed

• Conditions: COVID-19; Respiratory Failure

• Registration Number: NCT04354584
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-06
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-21
• Status Verified: 2022-01
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lymphocyte populations	Day 7	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
White blood cell counts	Day 7	Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood

Secondary Outcome Measures

Name	Time	Method
Cytokines	Day 7	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)
Microorganisms	Up to 12 weeks	Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)
Levels of SARS-CoV-2 in the airways	Day 7	Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid
Autoantibodies against type I IFNs in the airways	Day 0	Measured in bronchoalveolarlavage fluid
Lectin complement pathway	Day 7	MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma
Respiratory pathogens	Day 7	Respiratory filmarray PCR for testing for pathogens
Ribosomal RNA in the airways	Day 7	16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid
Surfactant in the airways	Day 0	Measured in bronchoalveolar lavage fluid by fourier-transform infrared spectroscopy using the dipalmitoylphosphatidylcholine\[DPPC\]/spingomyelin\[SM\]) ratio

Trial Locations

Locations (1)

Dept. of Intensive Care 542, University Hospital Hvidovre; 🇩🇰 Hvidovre, Copenhagen, Denmark