Renin Angiotensin System - CoronaVirus

Not Applicable

• Conditions: COVID 19
• Interventions: Other: blood draw

• Registration Number: NCT04337008
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-03
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-07
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-06-03
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive COVID 19 patient with no respiratory distress	blood draw	-
Positive COVID 19 patient with respiratory distress	blood draw	-

Primary Outcome Measures

Name	Time	Method
overactivity of the renin / aldosterone system	7 days	demonstrate overactivity of RAS in patients hospitalised in intensive car secondary to COVID-19 compared to control patients (COVID -19 hospitalised patients without complications ).

Trial Locations

Locations (1)

ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE; 🇫🇷 Marseille, France