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

NCT04337190 | Unknown

• 1 other identifier: COVID-ARA2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• ACE2 activity over time

  at the day of admission, day 3 and day 7

• Mortality at day 28

  day 28

• ARDS severity

  from the day of admission to day 7

• Duration of mechanical ventilation

  from the day of admission to day 28

• Need for prone positionning

  from the day of admission to day 28

Interventions

blood sampling BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• admission to the intensive care unit,
• with a proven COVID infection, responsible for acute respiratory failure
• agree with participation to the study.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital Angers

Angers, 49933, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for measurement of ACE 2 level and ACE 2 activity (ratio Angiotensin(1-7)/Angiotensin(1-10))

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre Asfar, MD, PhD

  CHU Angers, service de médecine intensive réanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Asfar, MD, PhD

CONTACT

+33241355865; piasfar@chu-angers.fr

Julien Demiselle, MD

CONTACT

+33241355865; julien.demiselle@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: April 3, 2020
• Primary Completion: October 6, 2020
• Study Completion: December 6, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)