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

NCT04524156 | Unknown

• 1 other identifier: P2020/238
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• 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

  6 months

• 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

  6 months

Study Arms (2)

COVIS 19 positive

ACTIVE COMPARATOR

Other: Physiology

COVID 19 negative

SHAM COMPARATOR

Other: Physiology

Interventions

Physiology 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; COVIS 19 positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Functional Status

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Sofia Morra, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Morra, MD

CONTACT

025555919; sofia.morra@erasme.ulb.ac.be

Nora Bahhodh

CONTACT

+3225558351; Service.Rech-biomed@erasme.ulb.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: August 24, 2020
• Study Start: October 4, 2020
• Primary Completion: September 4, 2021
• Study Completion: May 4, 2023
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

BE (1)