Renin Angiotensin System - CoronaVirus (SRA-COV)
Primary Purpose
COVID 19
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID 19
Eligibility Criteria
Inclusion Criteria:
- Positive COVID 19 patients hospitalized in conventionnal hospitalisation
- Patients hospitalized in intensive care secondary to COVID-19 : Patient under invasive mechanical ventilation (PaO2 / FiO2 ratio <300; PEEP> = 5 cmH20; PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample; PaO2 / FiO2 ratio> 300)
Exclusion Criteria:
- Minor patient
- Patient deprived of liberty
- Patient's refusal to participate in the study
- Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued
Sites / Locations
- ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLERecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Positive COVID 19 patient with no respiratory distress
Positive COVID 19 patient with respiratory distress
Arm Description
Outcomes
Primary Outcome Measures
overactivity of the renin / aldosterone system
demonstrate overactivity of RAS in patients hospitalised in intensive car secondary to COVID-19 compared to control patients (COVID -19 hospitalised patients without complications ).
Secondary Outcome Measures
Full Information
NCT ID
NCT04337008
First Posted
April 3, 2020
Last Updated
April 21, 2020
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04337008
Brief Title
Renin Angiotensin System - CoronaVirus
Acronym
SRA-COV
Official Title
Renin Angiotensin System - CoronaVirus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
June 3, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to demonstrate overactivation of Renin Angiotensine System (RAS) in positives COVID-19 patient, especially in those with the most serious clinical forms where the mortality of patients in intensive care is on average 50%.
We are expecting two groups: a group of 25 positive COVID 19 patients in intensive care and a group of 25 positive COVID 19 hospitalized patients in conventional hospitalisation. We will measure RAS, serum potassium and collect data on the treatment of these patients (especially antihypertensive therapy) one week apart (at the patient'entry into hospital and 7 days later).
This is a preliminary study that could possibly allow the start of a therapeutic trial in order to test the effectiveness of RAS blocker treatments in this condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positive COVID 19 patient with no respiratory distress
Arm Type
Active Comparator
Arm Title
Positive COVID 19 patient with respiratory distress
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood draw
Intervention Description
20 mL blood draw will be performed at J1 et J7
Primary Outcome Measure Information:
Title
overactivity of the renin / aldosterone system
Description
demonstrate overactivity of RAS in patients hospitalised in intensive car secondary to COVID-19 compared to control patients (COVID -19 hospitalised patients without complications ).
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive COVID 19 patients hospitalized in conventionnal hospitalisation
Patients hospitalized in intensive care secondary to COVID-19 : Patient under invasive mechanical ventilation (PaO2 / FiO2 ratio <300; PEEP> = 5 cmH20; PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample; PaO2 / FiO2 ratio> 300)
Exclusion Criteria:
Minor patient
Patient deprived of liberty
Patient's refusal to participate in the study
Patient for whom therapeutic limitation measures such as non-admission to intensive care have been issued
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Silhol, MD
Email
francois.silhol@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Garrido-Pradalie
Organizational Affiliation
ASSISTANCE PUBLIQUE HÔPITAUX de MARSEILLE
Official's Role
Study Director
Facility Information:
Facility Name
ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Silhol, MD
Email
francois.silhol@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Renin Angiotensin System - CoronaVirus
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