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Completed

NCT Number: NCT04354584

Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Intensive Care 542, University Hospital Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. White blood cell counts

    Time frame: Day 0 (subsequent to study inclusion in the ICU)

    Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood

  2. White blood cell counts

    Time frame: Day 7

    Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood

  3. Lymphocyte populations

    Time frame: Day 0 (subsequent to study inclusion in the ICU)

    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

  4. Lymphocyte populations

    Time frame: 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

Secondary outcomes

  1. Cytokines

    Time frame: Day 0 (subsequent to study inclusion in the ICU)

    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)

  2. Cytokines

    Time frame: 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)

  3. Lectin complement pathway

    Time frame: Day 0 (subsequent to study inclusion in the ICU)

    MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma

  4. Lectin complement pathway

    Time frame: Day 7

    MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma

  5. Microorganisms

    Time frame: Up to 12 weeks

    Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)

  6. Respiratory pathogens

    Time frame: Day 0 (subsequent to study inclusion in the ICU)

    Respiratory filmarray PCR for testing for pathogens

  7. Respiratory pathogens

    Time frame: Day 7

    Respiratory filmarray PCR for testing for pathogens

  8. Ribosomal RNA in the airways

    Time frame: Day 0 (subsequent to study inclusion in the ICU)

    16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid

  9. Ribosomal RNA in the airways

    Time frame: Day 7

    16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid

  10. Levels of SARS-CoV-2 in the airways

    Time frame: Day 0 (subsequent to study inclusion in the ICU)

    Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid

  11. Levels of SARS-CoV-2 in the airways

    Time frame: Day 7

    Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid

  12. Surfactant in the airways

    Time frame: Day 0

    Measured in bronchoalveolar lavage fluid by fourier-transform infrared spectroscopy using the dipalmitoylphosphatidylcholine[DPPC]/spingomyelin[SM]) ratio

  13. Autoantibodies against type I IFNs in the airways

    Time frame: Day 0

    Measured in bronchoalveolarlavage fluid

Other outcomes

  1. Mortality

    Time frame: Up to 6 months

    ICU mortality

  2. Mortality II

    Time frame: Up to 6 months

    In hospital mortality

  3. Blood markers of inflammation

    Time frame: Daily assessment in the ICU up to 12 weeks

    C-reactive protein, procalcitonin, ferritin

  4. Infiltrates on conventional chest x-ray

    Time frame: Up to 12 weeks

    Number of participants with unilateral infiltrates or bilateral infiltrates and/or air bronchogram

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Acronym: COV2ICU-DK

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2020
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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