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

Acute Respiratory Distress Syndrome Clinical Trial

— COVID-ARA2  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337190
• Other study ID #: COVID-ARA2
• Status: Recruiting
• Start date: April 3, 2020
• Est. completion date: December 6, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Angers
• Contact: Pierre Asfar, MD, PhD
• Phone: +33241355865
• Email: piasfar[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Biological:
• blood sampling
blood sampling at the day of admission, day 3 and day 7

Locations

Country	Name	City	State
France	University Hospital Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mortality at day 28	Mortality at day 28	day 28
Secondary	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
Secondary	Duration of mechanical ventilation	Day under mechanical ventilation	from the day of admission to day 28
Secondary	Need for prone positionning	Need for prone positionning	from the day of admission to day 28
Secondary	Need for extracorporeal membran oxygenation	Need for extracorporeal membran oxygenation	from the day of admission to day 28
Secondary	Use of paralytic agents	Need for use of paralytic agents	from the day of admission to day 28
Secondary	Need for renal replacement therapy	Need for renal replacement therapy	from the day of admission to day 28
Secondary	Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)	Need for vasoactive drugs	from the day of admission to day 28
Secondary	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
Secondary	Number of session(s) of prone positionning	Number of session(s) of prone positionning	from the day of admission to day 28
Secondary	Duration of extracorporeal membran oxygenation treatment	Duration of extracorporeal membran oxygenation treatment	from the day of admission to day 28
Secondary	Type of vasoactive drugs	Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues...	from the day of admission to day 28
Secondary	Duration of vasoactive treatment	Duration of vasoactive treatment	from the day of admission to day 28