COVIDCOVID-ARA2NCT04337190
Impact of Angiotensin II Receptor Blockers Treatment in Patients With COVID 19 (COVID-ARA2)
An observational study of COVID and Acute Respiratory Distress Syndrome, run by University Hospital, Angers at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Acute Respiratory Distress Syndrome
- What is being tested?
- blood sampling
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2020to 6 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- admission to the intensive care unit,
- with a proven COVID infection, responsible for acute respiratory failure
- agree with participation to the study.
Who cannot join
- aged under 18
- under legal protection
- pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Angers
Angers, 49933
Julien Demiselle, M.D., 33 (0)241355865, julien.demiselle@chu-angers.fr
About this study
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)
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.
Read more
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.
- Conditions
- COVID, Acute Respiratory Distress Syndrome
- Being tested
- blood sampling
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
blood sampling at the day of admission, day 3 and day 7
What is being measured
The primary outcome is the main question the study is designed to answer.
ACE2 level change over time
ELISA test (Higher the ACE2 level, higher the virus penetrate cells)
Measured: at the day of admission, day 3 and day 7
Secondary outcomes (14)
ACE2 activity over time
Ratio angiotensin (1-7)/angiotensin(1/10) (Higher Ratio angiotensin (1-7)/angiotensin(1/10), higher is ACE2 activity)
Measured: at the day of admission, day 3 and day 7
Mortality at day 28
Mortality at day 28
Measured: day 28
ARDS severity
PaO2/FiO2 ratio (ARDS is severe when <100, moderate when between 100 and 200, mild when >200)
Measured: from the day of admission to day 7
Duration of mechanical ventilation
Day under mechanical ventilation
Measured: from the day of admission to day 28
Need for prone positionning
Need for prone positionning
Measured: from the day of admission to day 28
Need for extracorporeal membran oxygenation
Need for extracorporeal membran oxygenation
Measured: from the day of admission to day 28
Use of paralytic agents
Need for use of paralytic agents
Measured: from the day of admission to day 28
Need for renal replacement therapy
Need for renal replacement therapy
Measured: from the day of admission to day 28
Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)
Need for vasoactive drugs
Measured: from the day of admission to day 28
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
Measured: from the day of admission to day 7
Number of session(s) of prone positionning
Number of session(s) of prone positionning
Measured: from the day of admission to day 28
Duration of extracorporeal membran oxygenation treatment
Duration of extracorporeal membran oxygenation treatment
Measured: from the day of admission to day 28
Type of vasoactive drugs
Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues...
Measured: from the day of admission to day 28
Duration of vasoactive treatment
Duration of vasoactive treatment
Measured: from the day of admission to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start3 Apr 2020
- Primary completion6 Oct 2020 (estimated)
- Study completion6 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre Asfar, MD, PhD, Principal investigator, CHU Angers, service de médecine intensive réanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337190
- Sponsor's protocol ID
- COVID-ARA2
- Acronym
- COVID-ARA2
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04337190
- Acronym / sponsor ID
- COVID-ARA2 / COVID-ARA2
- Conditions
- COVID, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 6 Oct 2020 (estimated)
- Study completion
- 6 Dec 2020 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- admission to the intensive care unit,
- with a proven COVID infection, responsible for acute respiratory failure
- agree with participation to the study.
Key exclusion criteria (3 listed)
- aged under 18
- under legal protection
- pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood sampling at the day of admission, day 3 and day 7 | Biological | – |
Primary outcome
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)
14 secondary outcomes
ACE2 activity over time
Time frame: at the day of admission, day 3 and day 7
Mortality at day 28
Time frame: day 28
ARDS severity
Time frame: from the day of admission to day 7
Duration of mechanical ventilation
Time frame: from the day of admission to day 28
Need for prone positionning
Time frame: from the day of admission to day 28
Need for extracorporeal membran oxygenation
Time frame: from the day of admission to day 28
Use of paralytic agents
Time frame: from the day of admission to day 28
Need for renal replacement therapy
Time frame: from the day of admission to day 28
Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)
Time frame: from the day of admission to day 28
Sequential Organ Failure Assessment (SOFA) score
Time frame: from the day of admission to day 7
Number of session(s) of prone positionning
Time frame: from the day of admission to day 28
Duration of extracorporeal membran oxygenation treatment
Time frame: from the day of admission to day 28
Type of vasoactive drugs
Time frame: from the day of admission to day 28
Duration of vasoactive treatment
Time frame: from the day of admission to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Asfar, MD, PhD principal investigator
CHU Angers, service de médecine intensive réanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Acute Respiratory Distress Syndrome, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Asfar, MD, PhD (+33241355865, piasfar@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACE2 level change over time (time frame: at the day of admission, day 3 and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.