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| ID | Type | Description | Link |
|---|---|---|---|
| H-20023159 | Other Identifier | Research Ethical Committee of The Capital Region of Denmark | |
| R349-2020-540 | Other Grant/Funding Number | The Lundbeck Foundation |
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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| White blood cell counts | Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood | Day 7 |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Cytokines |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | ICU mortality | Up to 6 months |
| Mortality II | In hospital mortality | Up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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Mechanically ventilated COVID-19 patients with ARDS included within 3 days of ICU admission
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| Name | Affiliation | Role |
|---|---|---|
| Ronni R Plovsing, MD, PhD | Dept. of Intensive Care, University Hospital Hvidovre, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Intensive Care 542, University Hospital Hvidovre | Hvidovre | Copenhagen | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35639922 | Derived | Fahnoe U, Ronit A, Berg RMG, Jorgensen SE, Mogensen TH, Underwood AP, Scheel TKH, Bukh J, Plovsing RR. A Distinct Dexamethasone-Dependent Gene Expression Profile in the Lungs of COVID-19 Patients. J Infect Dis. 2022 Dec 13;226(12):2137-2141. doi: 10.1093/infdis/jiac218. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Bronchoalveolar lavage fluid Plasma Whole blood
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 |
| 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) |
| Lectin complement pathway | MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma | Day 7 |
| Microorganisms | Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid) | Up to 12 weeks |
| Respiratory pathogens | Respiratory filmarray PCR for testing for pathogens | Day 0 (subsequent to study inclusion in the ICU) |
| Respiratory pathogens | Respiratory filmarray PCR for testing for pathogens | Day 7 |
| 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) |
| 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 |
| 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) |
| Levels of SARS-CoV-2 in the airways | Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid | Day 7 |
| Surfactant in the airways | Measured in bronchoalveolar lavage fluid by fourier-transform infrared spectroscopy using the dipalmitoylphosphatidylcholine[DPPC]/spingomyelin[SM]) ratio | Day 0 |
| Autoantibodies against type I IFNs in the airways | Measured in bronchoalveolarlavage fluid | Day 0 |
| Blood markers of inflammation | C-reactive protein, procalcitonin, ferritin | Daily assessment in the ICU up to 12 weeks |
| Infiltrates on conventional chest x-ray | Number of participants with unilateral infiltrates or bilateral infiltrates and/or air bronchogram | Up to 12 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |