Acute Respiratory Distress Syndrome, COVID
Conditions
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.
Interventions
BIOLOGICALblood sampling
blood sampling at the day of admission, day 3 and day 7
Sponsors
University Hospital, Angers
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACE2 level change over time | at the day of admission, day 3 and day 7 | ELISA test (Higher the ACE2 level, higher the virus penetrate cells) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at day 28 | day 28 | Mortality at day 28 |
| ARDS severity | 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) |
| Duration of mechanical ventilation | from the day of admission to day 28 | Day under mechanical ventilation |
| Need for prone positionning | from the day of admission to day 28 | Need for prone positionning |
| Need for extracorporeal membran oxygenation | from the day of admission to day 28 | Need for extracorporeal membran oxygenation |
| Use of paralytic agents | from the day of admission to day 28 | Need for use of paralytic agents |
| ACE2 activity over time | 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) |
| Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine) | from the day of admission to day 28 | Need for vasoactive drugs |
| Sequential Organ Failure Assessment (SOFA) score | 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 |
| Number of session(s) of prone positionning | from the day of admission to day 28 | Number of session(s) of prone positionning |
| Duration of extracorporeal membran oxygenation treatment | from the day of admission to day 28 | Duration of extracorporeal membran oxygenation treatment |
| Type of vasoactive drugs | from the day of admission to day 28 | Several vasoactive agents may be used: norepinephrine, dobutamine, epinephrine, vasopressin analogues... |
| Duration of vasoactive treatment | from the day of admission to day 28 | Duration of vasoactive treatment |
| Need for renal replacement therapy | from the day of admission to day 28 | Need for renal replacement therapy |
Countries
France
Contacts
Primary ContactPierre Asfar, MD, PhD
Backup ContactJulien Demiselle, MD
Outcome results
None listed