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Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19 (COV2ICU-DK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354584
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Ronni R. Plovsing, 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.

Condition or disease
COVID-19 Respiratory Failure

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified COVID-19
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : January 10, 2022
Actual Study Completion Date : January 10, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA
Bronchoalveolar lavage fluid Plasma Whole blood


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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
Mechanically ventilated COVID-19 patients with ARDS included within 3 days of ICU admission
Criteria

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

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): NCT04354584


Locations
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Denmark
Dept. of Intensive Care 542, University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Ronni R Plovsing, MD, PhD Dept. of Intensive Care, University Hospital Hvidovre, Denmark
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Responsible Party: Ronni R. Plovsing, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04354584    
Other Study ID Numbers: COV2ICU-DK
H-20023159 ( Other Identifier: Research Ethical Committee of The Capital Region of Denmark )
R349-2020-540 ( Other Grant/Funding Number: The Lundbeck Foundation )
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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