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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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COVID, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Biological: blood sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: blood sampling|blood sampling at the day of admission, day 3 and day 7|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Mortality at day 28 | Mortality at day 28 | day 28 | 
| 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 |