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SRA-COV: Renin Angiotensin System - CoronaVirus

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT04337008
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
3.9
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: blood draw
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Renin Angiotensin System - CoronaVirus
Actual Study Start Date :
Apr 3, 2020
Anticipated Primary Completion Date :
Jun 3, 2020
Anticipated Study Completion Date :
Jul 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Positive COVID 19 patient with no respiratory distress

Other: blood draw
20 mL blood draw will be performed at J1 et J7
Experimental: Positive COVID 19 patient with respiratory distress

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

Outcome Measures

Primary Outcome Measures

  1. 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 ).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ASSISTANCE PUBLIQUE HÖPITAUX de MARSEILLE Marseille France 13005

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Emilie Garrido-Pradalie, ASSISTANCE PUBLIQUE HÔPITAUX de MARSEILLE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT04337008
Other Study ID Numbers:
  • 2020-16
  • 2020-A00795-34
First Posted:
Apr 7, 2020
Last Update Posted:
Apr 24, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronavirus Infections

Study Results

No Results Posted as of Apr 24, 2020