COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2

NCT ID: NCT04524156

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-04
• Study Completion Date: 2023-05-04

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.

Conditions

COVID; Acute Respiratory Distress Syndrome; Endothelial Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

COVIS 19 positive

Group Type: ACTIVE_COMPARATOR

Physiology

Intervention Type: OTHER

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).

COVID 19 negative

Group Type: SHAM_COMPARATOR

Physiology

Intervention Type: OTHER

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).

Interventions

Physiology

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• SARS-CoV2 infection (PCR positive and/or TDM Imaging)

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sofia Morra, MD

Role: PRINCIPAL_INVESTIGATOR

Erasme hospital

Locations

Erasme Hospital

Brussels, , Belgium

Countries

Belgium

Central Contacts

Sofia Morra, MD

Role: CONTACT

sofia.morra@erasme.ulb.ac.be

025555919 ext. 5919

Nora Bahhodh

Role: CONTACT

Service.Rech-biomed@erasme.ulb.ac.be

+3225558351

Other Identifiers

P2020/238

Identifier Type: -

Identifier Source: org_study_id