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

• Conditions: COVID; Acute Respiratory Distress Syndrome

• Registration Number: NCT04337190
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

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 Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-03
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-04
• Study First Posted: 2020-04-07
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10
• Primary Completion: 2020-10-06
• Study Completion: 2020-12-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ACE2 activity over time	at the day of admission, day 3 and day 7	Ratio angiotensin (1-7)/angiotensin(1/10) (Higher Ratio angiotensin (1-7)/angiotensin(1/10), higher is ACE2 activity)
Mortality at day 28	day 28	Mortality at day 28
ARDS severity	from the day of admission to day 7	PaO2/FiO2 ratio (ARDS is severe when \<100, moderate when between 100 and 200, mild when \>200)
Duration of mechanical ventilation	from the day of admission to day 28	Day under mechanical ventilation
Need for extracorporeal membran oxygenation	from the day of admission to day 28	Need for extracorporeal membran oxygenation
Use of paralytic agents	from the day of admission to day 28	Need for use of paralytic agents
Number of session(s) of prone positionning	from the day of admission to day 28	Number of session(s) of prone positionning
Duration of extracorporeal membran oxygenation treatment	from the day of admission to day 28	Duration of extracorporeal membran oxygenation treatment
Need for prone positionning	from the day of admission to day 28	Need for prone positionning
Need for renal replacement therapy	from the day of admission to day 28	Need for renal replacement therapy
Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)	from the day of admission to day 28	Need for vasoactive drugs
Duration of vasoactive treatment	from the day of admission to day 28	Duration of vasoactive treatment
Sequential Organ Failure Assessment (SOFA) score	from the day of admission to day 7	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
Type of vasoactive drugs	from the day of admission to day 28	Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues...

Trial Locations

Locations (1)

University Hospital Angers; 🇫🇷 Angers, France