CClinicalTrials.gg
Status unknownNCT04337190COVID-ARA2Updated Apr 10, 2020

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

An observational study in COVID and Acute Respiratory Distress Syndrome, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-10.

Sponsored by University Hospital, Angers · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • aged under 18
  • under legal protection
  • pregnant or breastfeeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Biologicalblood sampling

    blood sampling at the day of admission, day 3 and day 7

06

What researchers measure

Primary outcomes

  1. ACE2 level change over time

    ELISA test (Higher the ACE2 level, higher the virus penetrate cells)

    Time frame: at the day of admission, day 3 and day 7

Secondary outcomes

  1. ACE2 activity over time

    Ratio angiotensin (1-7)/angiotensin(1/10) (Higher Ratio angiotensin (1-7)/angiotensin(1/10), higher is ACE2 activity)

    Time frame: at the day of admission, day 3 and day 7

  2. Mortality at day 28

    Mortality at day 28

    Time frame: day 28

  3. ARDS severity

    PaO2/FiO2 ratio (ARDS is severe when \<100, moderate when between 100 and 200, mild when \>200)

    Time frame: from the day of admission to day 7

  4. Duration of mechanical ventilation

    Day under mechanical ventilation

    Time frame: from the day of admission to day 28

  5. Need for prone positionning

    Need for prone positionning

    Time frame: from the day of admission to day 28

  6. Need for extracorporeal membran oxygenation

    Need for extracorporeal membran oxygenation

    Time frame: from the day of admission to day 28

  7. Use of paralytic agents

    Need for use of paralytic agents

    Time frame: from the day of admission to day 28

  8. Need for renal replacement therapy

    Need for renal replacement therapy

    Time frame: from the day of admission to day 28

  9. Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)

    Need for vasoactive drugs

    Time frame: from the day of admission to day 28

  10. 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

    Time frame: from the day of admission to day 7

  11. Number of session(s) of prone positionning

    Number of session(s) of prone positionning

    Time frame: from the day of admission to day 28

  12. Duration of extracorporeal membran oxygenation treatment

    Duration of extracorporeal membran oxygenation treatment

    Time frame: from the day of admission to day 28

  13. Type of vasoactive drugs

    Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues...

    Time frame: from the day of admission to day 28

  14. Duration of vasoactive treatment

    Duration of vasoactive treatment

    Time frame: from the day of admission to day 28

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04337190
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Apr 7, 2020
Start date
Apr 3, 2020
Primary completion
Oct 6, 2020 (estimated)
Completion
Dec 6, 2020 (estimated)
Last update
Apr 10, 2020

Study contacts

Pierre Asfar, MD, PhD
Contact
piasfar@chu-angers.fr
+33241355865
Julien Demiselle, MD
Contact
julien.demiselle@chu-angers.fr
+33241355865
Pierre Asfar, MD, PhD
principal investigator · CHU Angers, service de médecine intensive réanimation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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