Renin Angiotensin System - CoronaVirus
SRA-COV
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2020
CompletedStudy Start
First participant enrolled
April 3, 2020
CompletedFirst Posted
Study publicly available on registry
April 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedApril 24, 2020
April 1, 2020
2 months
April 3, 2020
April 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 ).
7 days
Study Arms (2)
Positive COVID 19 patient with no respiratory distress
ACTIVE COMPARATORPositive COVID 19 patient with respiratory distress
EXPERIMENTALInterventions
20 mL blood draw will be performed at J1 et J7
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE
Marseille, 13005, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emilie Garrido-Pradalie
ASSISTANCE PUBLIQUE HÔPITAUX de MARSEILLE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2020
First Posted
April 7, 2020
Study Start
April 3, 2020
Primary Completion
June 3, 2020
Study Completion
July 31, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share