NCT04354584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

April 13, 2020

Last Update Submit

January 10, 2022

Conditions

COVID-19Respiratory Failure

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (13)

  • Cytokines

    Day 0 (subsequent to study inclusion in the ICU)

  • Cytokines

    Day 7

  • Lectin complement pathway

    Day 0 (subsequent to study inclusion in the ICU)

  • Lectin complement pathway

    Day 7

  • Microorganisms

    Up to 12 weeks

  • +8 more secondary outcomes

Other Outcomes (4)

  • Mortality

    Up to 6 months

  • Mortality II

    Up to 6 months

  • Blood markers of inflammation

    Daily assessment in the ICU up to 12 weeks

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age \> 18y
  • Mechanical ventilation
  • Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)
  • ARDS according to the Berlin definition

You may not qualify if:

  • Untreated malignant tachycardia or bradycardia
  • Suspected or verified intracranial hypertension (ICP \> 15 mmHg)
  • Unilateral lung ventilation
  • Severe non-correctable coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Intensive Care 542, University Hospital Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 35639922DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid Plasma Whole blood

MeSH Terms

Conditions

COVID-19Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Ronni R Plovsing, MD, PhD

    Dept. of Intensive Care, University Hospital Hvidovre, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 21, 2020

Study Start

April 6, 2020

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

DK(1)