Impact of Angiotensin II Receptor Blockers Treatment in Patients With COVID 19 (COVID-ARA2) (COVID-ARA2)

Impact of Previous Treatment With Angiotensin II Receptor Blockers in Patients With SARS-Cov2 Infection Admitted to the Intensive Care Unit on Survival and Severity of the Disease (COVID-ARA2)

The actual pandemic infection related to SARS-CoV2 results in viral pneumonitis (COVID-19), that may, in the more severe cases, lead the patients to the intensive care unit (ICU). The more frequent presentation is acute respiratory distress syndrome (ARDS).

To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor.

ACE2 belong to the renin-angiotensin-aldosteron system (SRAA), and ACE2 levels are directly modified when SRAA inhibitors are administred to patients, and ACE2 level increases particularely with Angiotensin II Receptor blockers (ARA2) use.

The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU).

COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.

Study Overview

• Status: Unknown
• Conditions: COVID; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Biological: blood sampling

Detailed Description

The actual pandemic infection related to SARS-CoV2 results in viral pneumonitis (COVID-19), that may, in the more severe cases, lead the patients to the intensive care unit (ICU). The more frequent presentation is acute respiratory distress syndrome (ARDS).

To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor.

ACE2 belong to the renin-angiotensin-aldosteron system (SRAA), and ACE2 levels are directly modified when SRAA inhibitors are administred to patients, and ACE2 level increases particularely with Angiotensin II Receptor Blockers (ARA2) use.

The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU).

COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • University Hospital Angers
    • Contact: Julien Demiselle, M.D.; Phone Number: 33 (0)241355865; Email: julien.demiselle@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants :

• will be admitted to the ICU for respiratory failure in a context of proven COVID.
• will be, or not, treated for chronic hypertension,
• will need, or not, mechanical ventilation.

Description

Inclusion Criteria:

• admission to the intensive care unit,
• with a proven COVID infection, responsible for acute respiratory failure
• agree with participation to the study.

Exclusion Criteria:

• aged under 18
• under legal protection
• pregnant or breastfeeding

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACE2 level change over time	ELISA test (Higher the ACE2 level, higher the virus penetrate cells)	at the day of admission, day 3 and day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at day 28	Mortality at day 28	day 28
ACE2 activity over time	Ratio angiotensin (1-7)/angiotensin(1/10) (Higher Ratio angiotensin (1-7)/angiotensin(1/10), higher is ACE2 activity)	at the day of admission, day 3 and day 7
ARDS severity	PaO2/FiO2 ratio (ARDS is severe when <100, moderate when between 100 and 200, mild when >200)	from the day of admission to day 7
Duration of mechanical ventilation	Day under mechanical ventilation	from the day of admission to day 28
Need for prone positionning	Need for prone positionning	from the day of admission to day 28
Need for extracorporeal membran oxygenation	Need for extracorporeal membran oxygenation	from the day of admission to day 28
Use of paralytic agents	Need for use of paralytic agents	from the day of admission to day 28
Need for renal replacement therapy	Need for renal replacement therapy	from the day of admission to day 28
Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)	Need for vasoactive drugs	from the day of admission to day 28
Sequential Organ Failure Assessment (SOFA) score	The SOFA score evaluates the severity of patients through 6 items: respiration (PaO2/FiO2 ratio); coagulation (platelets count); liver (bilirubin); Cardiovascular (hypotension); Central nervous system (coma glasgow score) and Renal (creatinine serum level). Score ranges from 0 to 24, a higher score indicates higher severity and probability of death	from the day of admission to day 7
Number of session(s) of prone positionning	Number of session(s) of prone positionning	from the day of admission to day 28
Duration of extracorporeal membran oxygenation treatment	Duration of extracorporeal membran oxygenation treatment	from the day of admission to day 28
Type of vasoactive drugs	Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues...	from the day of admission to day 28
Duration of vasoactive treatment	Duration of vasoactive treatment	from the day of admission to day 28

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Pierre Asfar, MD, PhD, CHU Angers, service de médecine intensive réanimation

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Anticipated): October 6, 2020
• Study Completion (Anticipated): December 6, 2020

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 4, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: COVID-ARA2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No