COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2 (COVID-pO2-RAAS)
Primary Purpose
COVID, Acute Respiratory Distress Syndrome, Endothelial Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Physiology
Sponsored by
About this trial
This is an interventional basic science trial for COVID
Eligibility Criteria
Inclusion Criteria:
- SARS-CoV2 infection (PCR positive and/or TDM Imaging)
Exclusion Criteria:
- None
Sites / Locations
- Erasme Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
COVIS 19 positive
COVID 19 negative
Arm Description
Outcomes
Primary Outcome Measures
Transcutaneous pO2 and pCO2 as predictive factors for respiratory deterioration
To test the prognostic utility of TcpO2 and TcpCO2 for the prediction of COVID19 related lung injury and acute respiratory distress syndrome (ARDS) compared to finger oxygen saturation.
Pneumoproteins CC16 and SDP as predictive factors for respiratory deterioration
To test the prognostic utility of CC16 and SPD in patients with COVID19-related acute lung injury
Diagnostic and prognostic utility of plasma concentration of ACE2, Ang II, Ang 1-7, Ang 1-9 in COVID-19
To test the hypothesis that plasma concentration of ACE2, AngII, Ang 1-7 and Ang 1-9 are profoundly impaired in COVID-19 and may be predictive factors of clinical deterioration
Secondary Outcome Measures
Full Information
NCT ID
NCT04524156
First Posted
April 30, 2020
Last Updated
August 21, 2020
Sponsor
Erasme University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04524156
Brief Title
COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2
Acronym
COVID-pO2-RAAS
Official Title
COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2020 (Anticipated)
Primary Completion Date
September 4, 2021 (Anticipated)
Study Completion Date
May 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The first case of a person infected with SARS-Cov-2 virus can be tracked back on November the 17th, 2019, in China. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 outbreak a pandemic. On April 13, COVID-19 is affecting 210 countries and territories worldwide, about 2 million positive cases have been officially declared along with 115.000 deaths. The real number of infected and deaths is scarily higher, considering that up to 65% people are asymptomatic and thus, not tested.
The percentage of patients with COVID-19 needed for intensive care unit (ICU) varied from 5 to 32% in Wuhan, China. It was up to 9% in Lombardy, Italy. According to available data from Lombardy, 99% of patients admitted to the ICU needed respiratory support (88% invasive ventilation, 11% non invasive ventilation).
The aim of the present investigation is to test the hypothesis whether transcutaneous partial O2 and CO2 pressures may be reliable predictive factors for acute respiratory distress syndrome (ARDS) development in hospitalized clinically stable COVID-19 positive patients and to clarify the role of the Angiotensin Converting Enzyme 2 (ACE2) and its final product, angiotensin 2 (Ang II) in the pathogenesis of this systemic disease.
We also aim to test the hypothesis that plasma concentration of Clara Cell protein (CC16) and surfactant protein D (SPD), which are a biomarkers of acute lung injury, are severely decreased in COVID-19 positive patients and the plasma concentration is related to the severity of lung injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Acute Respiratory Distress Syndrome, Endothelial Dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COVIS 19 positive
Arm Type
Active Comparator
Arm Title
COVID 19 negative
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Physiology
Intervention Description
Percutaneous O2 and CO2 partial pressures. A PeriFlux system 5000 (Perimed©, Järfälla, Sweden) will be used to monitor TcpO2 and TcpCO2 tensions by means of a PF 5040 unit and a dual TcpO2/CO2 E5280 electrode. The E5280 electrode, covered by a membrane permeable to oxygen (O2) and carbon dioxide (CO2) heats (44°C) the underlying tissue to maximize gas diffusion through the skin. .
Pulse Oximeter and hemodynamic parameters Pulse oximeter is a portable device largely used to measure real time finger oxygen saturation (SatO2) and heart rate Blood collection After the above said measurements, a venous blood simple will be realized. Plasma concentration of ACE2, Angiotensin II, Angiotensin 1-7, angiotensin 1-9, CC16, will be measured at the Erasme hospital (ELISA method).
Primary Outcome Measure Information:
Title
Transcutaneous pO2 and pCO2 as predictive factors for respiratory deterioration
Description
To test the prognostic utility of TcpO2 and TcpCO2 for the prediction of COVID19 related lung injury and acute respiratory distress syndrome (ARDS) compared to finger oxygen saturation.
Time Frame
6 months
Title
Pneumoproteins CC16 and SDP as predictive factors for respiratory deterioration
Description
To test the prognostic utility of CC16 and SPD in patients with COVID19-related acute lung injury
Time Frame
6 months
Title
Diagnostic and prognostic utility of plasma concentration of ACE2, Ang II, Ang 1-7, Ang 1-9 in COVID-19
Description
To test the hypothesis that plasma concentration of ACE2, AngII, Ang 1-7 and Ang 1-9 are profoundly impaired in COVID-19 and may be predictive factors of clinical deterioration
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
SARS-CoV2 infection (PCR positive and/or TDM Imaging)
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Morra, MD
Phone
025555919
Ext
5919
Email
sofia.morra@erasme.ulb.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Nora Bahhodh
Phone
+3225558351
Email
Service.Rech-biomed@erasme.ulb.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Morra, MD
Organizational Affiliation
Erasme hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2
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