Renin Angiotensin System - CoronaVirus

COVID 19 Clinical Trial

— SRA-COV  

Official title:

Renin Angiotensin System - CoronaVirus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337008
• Other study ID #: 2020-16
• Secondary ID: 2020-A00795-34
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2020
• Source: Assistance Publique Hopitaux De Marseille
• Contact: François Silhol, MD
• Email: francois.silhol[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID 19

Intervention

Other:
• blood draw
20 mL blood draw will be performed at J1 et J7

Locations

Country	Name	City	State
France	ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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