Renin Angiotensin System - CoronaVirus

NCT ID: NCT04337008

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-03
• Study Completion Date: 2020-07-31

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.

Conditions

COVID 19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Positive COVID 19 patient with no respiratory distress

Group Type: ACTIVE_COMPARATOR

blood draw

Intervention Type: OTHER

20 mL blood draw will be performed at J1 et J7

Positive COVID 19 patient with respiratory distress

Group Type: EXPERIMENTAL

blood draw

Intervention Type: OTHER

20 mL blood draw will be performed at J1 et J7

Interventions

blood draw

20 mL blood draw will be performed at J1 et J7

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Garrido-Pradalie

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE HÔPITAUX de MARSEILLE

Locations

ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François Silhol, MD

Role: CONTACT

francois.silhol@ap-hm.fr

Facility Contacts

Francois Silhol, MD

Role: primary

francois.silhol@ap-hm.fr

Other Identifiers

2020-A00795-34

Identifier Type: OTHER

Identifier Source: secondary_id

2020-16

Identifier Type: -

Identifier Source: org_study_id