Status:
COMPLETED
COVID-19 Associated Endothelial Dysfunction Study
Lead Sponsor:
University Hospital, Angers
Conditions:
Covid19
Microcirculation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
SARS-CoV-2 enters human cells through the binding of the spike protein with angiotensin converting enzyme-2 (ACE2), a membrane receptor highly expressed in immune or non-immune cells, and in many orga...
Detailed Description
This cohort study compares 3 exposure cohorts : Cohort C1 includes COVID19 (+) patients admitted in ICU in whom the diagnosis of COVID19 pneumonia was confirmed. Cohort C2 includes COVID 19 (-) matc...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Adult patient (≥ 18 ans)
- Affiliation to the French National Healthcare System
- Voluntary patient who have given oral consent
- Cohort C1, COVID19 (+) patients hospitalized in ICU :
- Patient admitted to ICU within 72 hours before inclusion
- Patient presenting SARS-COV2 pneumonia diagnosed by CT scan or by COVID-19 PCR test.
- Cohort C2, COVID19 (-) patients hospitalized in ICU :
- Patient admitted to ICU within 72 hours before inclusion
- All COVID19 PCR tests carried out in the 15 days prior inclusion are negative
- All the CT scans possibly performed since the acute event do not show COVID19 pulmonary lesions
- Matching with the cases C1 COVID 19 (+) patients on sex, age (threshold at 65 years), treated hypertension, treated diabetes mellitus.
- Cohort C3, elective surgery patients who are not hospitalized in ICU :
- ASA 1 classification (no major comorbidity, a normaly healthy patient)
- Asymptomatic to COVID19 according to French Anesthesiology Society 2020 :
- No major symptoms among : measured fever \> 38°C, dry cough, shortness of breath or high respiratory rate (\>20/min), anosmia, ageusia
- No more than one minor symptom among : sore throat, rhinorrhea, chest pain, myalgia, general alteration or severe tiredness, confusion, disorientation, headache, diarrhea, nausea or/and vomiting, rash/ frostbite/cracking on fingers or hand
- No positive COVID19 PCR test within 15 days prior to inclusion
- Non-inclusion criteria :
- Proven sepsis (Procalcitonin \>1.0 µg/l) in the 24 hours prior to inclusion
- End-stage kidney disease with dialysis
- Patient with haemodynamic failure treated by norepinephrine
- Patient with traumatic brain injury
- Intubated patient and/or sedated
- Pregnant woman, parturient and nursing mother
- Person restricted in liberty by an administrative or judicial decision
- Patient concerned with admission for psychiatric care
- Adult person subject to a legal protection measure or unable to express consent
- Exclusion criteria :
- • Cohorts C2 and C3 : positive COVID-19 PCR test within 5 days after inclusion
Exclusion
Key Trial Info
Start Date :
October 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04773899
Start Date
October 22 2021
End Date
December 21 2022
Last Update
May 6 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
UH Angers
Angers, France, 49933
2
Hopital E.Herriot - Hospices Civils de Lyon
Lyon, France, 69437