COVID-19COV2ICU-DKNCT04354584
Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19
An observational study of COVID-19 and Respiratory Failure, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Respiratory Failure
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Apr 2020to 10 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated COVID-19 patients with ARDS included within 3 days of ICU admission
Who may be able to join
- Age > 18y
- Mechanical ventilation
- Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)
- ARDS according to the Berlin definition
Who cannot join
- Untreated malignant tachycardia or bradycardia
- Suspected or verified intracranial hypertension (ICP > 15 mmHg)
- Unilateral lung ventilation
- Severe non-correctable coagulopathy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Intensive Care 542, University Hospital Hvidovre
Hvidovre, Copenhagen, 2650
About this study
Official title: Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified 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.
Read the 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.
- Conditions
- COVID-19, Respiratory Failure
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
White blood cell counts
Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
Measured: 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
Measured: 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
Measured: 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
Measured: Day 7
Secondary outcomes (13)
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)
Measured: Day 0 (subsequent to study inclusion in the ICU)
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)
Measured: Day 7
Lectin complement pathway
MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma
Measured: 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
Measured: Day 7
Microorganisms
Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)
Measured: Up to 12 weeks
Respiratory pathogens
Respiratory filmarray PCR for testing for pathogens
Measured: Day 0 (subsequent to study inclusion in the ICU)
Respiratory pathogens
Respiratory filmarray PCR for testing for pathogens
Measured: 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
Measured: 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
Measured: Day 7
Levels of SARS-CoV-2 in the airways
Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid
Measured: 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
Measured: Day 7
Surfactant in the airways
Measured in bronchoalveolar lavage fluid by fourier-transform infrared spectroscopy using the dipalmitoylphosphatidylcholine[DPPC]/spingomyelin[SM]) ratio
Measured: Day 0
Autoantibodies against type I IFNs in the airways
Measured in bronchoalveolarlavage fluid
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start6 Apr 2020
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronni R. Plovsing, Hvidovre University Hospital
- Investigators
- Ronni R Plovsing, MD, PhD, Principal investigator, Dept. of Intensive Care, University Hospital Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354584
- Sponsor's protocol ID
- COV2ICU-DK
- Other IDs
- H-20023159, R349-2020-540
- Acronym
- COV2ICU-DK
- Status last verified
- Jan 2022
- First submitted
- 13 Apr 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35639922
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified COVID-19
- ClinicalTrials.gov ID
- NCT04354584
- Acronym / sponsor ID
- COV2ICU-DK / COV2ICU-DK
- Conditions
- COVID-19, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated COVID-19 patients with ARDS included within 3 days of ICU admission
Key inclusion criteria (4 listed)
- Age > 18y
- Mechanical ventilation
- Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)
- ARDS according to the Berlin definition
Key exclusion criteria (4 listed)
- Untreated malignant tachycardia or bradycardia
- Suspected or verified intracranial hypertension (ICP > 15 mmHg)
- Unilateral lung ventilation
- Severe non-correctable coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
White blood cell counts
Time frame: Day 7
Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
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
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
13 secondary outcomes
Cytokines
Time frame: Day 0 (subsequent to study inclusion in the ICU)
Cytokines
Time frame: Day 7
Lectin complement pathway
Time frame: Day 0 (subsequent to study inclusion in the ICU)
Lectin complement pathway
Time frame: Day 7
Microorganisms
Time frame: Up to 12 weeks
Respiratory pathogens
Time frame: Day 0 (subsequent to study inclusion in the ICU)
Respiratory pathogens
Time frame: Day 7
Ribosomal RNA in the airways
Time frame: Day 0 (subsequent to study inclusion in the ICU)
Ribosomal RNA in the airways
Time frame: Day 7
Levels of SARS-CoV-2 in the airways
Time frame: Day 0 (subsequent to study inclusion in the ICU)
Levels of SARS-CoV-2 in the airways
Time frame: Day 7
Surfactant in the airways
Time frame: Day 0
Autoantibodies against type I IFNs in the airways
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 35639922Fahnoe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronni R Plovsing, MD, PhD principal investigator
Dept. of Intensive Care, University Hospital Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Respiratory Failure, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White blood cell counts (time frame: Day 0 (subsequent to study inclusion in the ICU)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.