Clinical trial NCT04337190: Impact of Angiotensin II Receptor Blockers Treatment in Patients With COVID 19 (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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Acute Respiratory Distress Syndrome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ACE2 level change over time
timeFrame: at the day of admission, day 3 and day 7
Secondary outcomes:
measure: ACE2 activity over time
timeFrame: at the day of admission, day 3 and day 7
measure: Mortality at day 28
timeFrame: day 28
measure: ARDS severity
timeFrame: from the day of admission to day 7
measure: Duration of mechanical ventilation
timeFrame: from the day of admission to day 28
measure: Need for prone positionning
timeFrame: from the day of admission to day 28
measure: Need for extracorporeal membran oxygenation
timeFrame: from the day of admission to day 28
measure: Use of paralytic agents
timeFrame: from the day of admission to day 28
measure: Need for renal replacement therapy
timeFrame: from the day of admission to day 28
measure: Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)
timeFrame: from the day of admission to day 28
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: from the day of admission to day 7
measure: Number of session(s) of prone positionning
timeFrame: from the day of admission to day 28
measure: Duration of extracorporeal membran oxygenation treatment
timeFrame: from the day of admission to day 28
measure: Type of vasoactive drugs
timeFrame: from the day of admission to day 28
measure: Duration of vasoactive treatment
timeFrame: from the day of admission to day 28
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
Study officials:
affiliation: CHU Angers, service de médecine intensive réanimation
name: Pierre Asfar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: