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Clinical Trials/NCT04354584
NCT04354584
Completed
Not Applicable

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

Hvidovre University Hospital1 site in 1 country20 target enrollmentApril 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Hvidovre University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Lymphocyte populations
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 6, 2020
End Date
January 10, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ronni R. Plovsing

MD, PhD

Hvidovre University Hospital

Eligibility 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

Outcomes

Primary Outcomes

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

White blood cell counts

Time Frame: Day 7

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

Secondary Outcomes

  • Cytokines(Day 7)
  • Microorganisms(Up to 12 weeks)
  • Levels of SARS-CoV-2 in the airways(Day 7)
  • Autoantibodies against type I IFNs in the airways(Day 0)
  • Lectin complement pathway(Day 7)
  • Respiratory pathogens(Day 7)
  • Ribosomal RNA in the airways(Day 7)
  • Surfactant in the airways(Day 0)

Study Sites (1)

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