Clinical trial NCT04354584: Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19
Official title: Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Respiratory Failure
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated COVID-19 patients with ARDS included within 3 days of ICU admission

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.

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

Primary outcomes:
measure: White blood cell counts
timeFrame: Day 0 (subsequent to study inclusion in the ICU)
measure: White blood cell counts
timeFrame: Day 7
measure: Lymphocyte populations
timeFrame: Day 0 (subsequent to study inclusion in the ICU)
measure: Lymphocyte populations
timeFrame: Day 7
Secondary outcomes:
measure: Cytokines
timeFrame: Day 0 (subsequent to study inclusion in the ICU)
measure: Cytokines
timeFrame: Day 7
measure: Lectin complement pathway
timeFrame: Day 0 (subsequent to study inclusion in the ICU)
measure: Lectin complement pathway
timeFrame: Day 7
measure: Microorganisms
timeFrame: Up to 12 weeks
measure: Respiratory pathogens
timeFrame: Day 0 (subsequent to study inclusion in the ICU)
measure: Respiratory pathogens
timeFrame: Day 7
measure: Ribosomal RNA in the airways
timeFrame: Day 0 (subsequent to study inclusion in the ICU)
measure: Ribosomal RNA in the airways
timeFrame: Day 7
measure: Levels of SARS-CoV-2 in the airways
timeFrame: Day 0 (subsequent to study inclusion in the ICU)
measure: Levels of SARS-CoV-2 in the airways
timeFrame: Day 7
measure: Surfactant in the airways
timeFrame: Day 0
measure: Autoantibodies against type I IFNs in the airways
timeFrame: Day 0
Other outcomes:
measure: Mortality
timeFrame: Up to 6 months
measure: Mortality II
timeFrame: Up to 6 months
measure: Blood markers of inflammation
timeFrame: Daily assessment in the ICU up to 12 weeks
measure: Infiltrates on conventional chest x-ray
timeFrame: Up to 12 weeks
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Intensive Care 542, University Hospital Hvidovre
state: Copenhagen
Study officials:
affiliation: Dept. of Intensive Care, University Hospital Hvidovre, Denmark
name: Ronni R Plovsing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: