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

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ClinicalTrials.gov Identifier: NCT04337190
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
COVID Acute Respiratory Distress Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : October 6, 2020
Estimated Study Completion Date : December 6, 2020



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


Primary Outcome Measures :
  1. ACE2 level change over time [ Time Frame: at the day of admission, day 3 and day 7 ]
    ELISA test (Higher the ACE2 level, higher the virus penetrate cells)


Secondary Outcome Measures :
  1. ACE2 activity over time [ Time Frame: 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)

  2. Mortality at day 28 [ Time Frame: day 28 ]
    Mortality at day 28

  3. ARDS severity [ Time Frame: 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)

  4. Duration of mechanical ventilation [ Time Frame: from the day of admission to day 28 ]
    Day under mechanical ventilation

  5. Need for prone positionning [ Time Frame: from the day of admission to day 28 ]
    Need for prone positionning

  6. Need for extracorporeal membran oxygenation [ Time Frame: from the day of admission to day 28 ]
    Need for extracorporeal membran oxygenation

  7. Use of paralytic agents [ Time Frame: from the day of admission to day 28 ]
    Need for use of paralytic agents

  8. Need for renal replacement therapy [ Time Frame: from the day of admission to day 28 ]
    Need for renal replacement therapy

  9. Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine) [ Time Frame: from the day of admission to day 28 ]
    Need for vasoactive drugs

  10. Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 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

  11. Number of session(s) of prone positionning [ Time Frame: from the day of admission to day 28 ]
    Number of session(s) of prone positionning

  12. Duration of extracorporeal membran oxygenation treatment [ Time Frame: from the day of admission to day 28 ]
    Duration of extracorporeal membran oxygenation treatment

  13. Type of vasoactive drugs [ Time Frame: from the day of admission to day 28 ]
    Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues...

  14. Duration of vasoactive treatment [ Time Frame: from the day of admission to day 28 ]
    Duration of vasoactive treatment


Biospecimen Retention:   Samples Without DNA
Blood sample for measurement of ACE 2 level and ACE 2 activity (ratio Angiotensin(1-7)/Angiotensin(1-10))


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337190


Contacts
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Contact: Pierre Asfar, MD, PhD +33241355865 piasfar@chu-angers.fr
Contact: Julien Demiselle, MD +33241355865 julien.demiselle@chu-angers.fr

Locations
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France
University Hospital Angers Recruiting
Angers, France, 49933
Contact: Julien Demiselle, M.D.    33 (0)241355865    julien.demiselle@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Pierre Asfar, MD, PhD CHU Angers, service de médecine intensive réanimation
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04337190    
Other Study ID Numbers: COVID-ARA2
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury