osartan and spironolactone treatment for COVID-19 patients with acute respiratory failure in intensive care unit

Phase 1

• Conditions: Patients with Covid-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001766-11-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-15
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Major patient
Patient with respiratory distress requiring oxygen support greater than or equal to 6 liters per minute.
News-Score greater than 6
PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample,
Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Minor patient,
Patient deprived of liberty,
Patient's refusal to participate in the study,
Patient for whom therapeutic limitation measures have been issued justifying the absence of mechanical ventilation,
Patient aged 80 or over,
Hypotension justifying treatment with noradrenaline,
Acute renal failure with a clearance of less than 60ml / min,
Severe liver failure.
Intolerance or contraindication to losartan or spironolactone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show the interest of treatment with losartan and spironolactone in patients infected with COVID-19 and suffering from acute respiratory distress syndrome on the impact of organ failures judged on the SOFA score on the 7th day post-inclusion;Secondary Objective: Show the interest of ARA2 / Spironolactone treatment on organ failures judged on the SOFA score on the 3rd, 14th, 21st, 28th day post-inclusion.<br>Show the interest of ARA2 / Spironolactone treatment on oxygenation based on the PaO2 / FiO2 ratio.<br>Show the interest of ARA2 / Spironolactone treatment for the duration of mechanical ventilation.<br>To show the interest of ARA2 / Spironolactone treatment on mortality.<br>Evaluate the clinical and biological tolerance of these treatments.;Primary end point(s): Organ failures will be assessed on the SOFA score;Timepoint(s) of evaluation of this end point: 7th day post-inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Organ failures will be assessed on the SOFA score<br>Oxygenation will be assessed using the PaO2 / FiO2 report<br>The duration of mechanical ventilation will be evaluated by the number of ventilation days, the number of days without ventilation between inclusion and death or D28.<br>Mortality will be measured by: mortality on D28, hospital mortality, resuscitation mortality.<br>The clinical tolerance will be evaluated by the permanent measurement of blood pressure, heart rate and diuresis, biological by the assays of urea, creatinine, potassium and markers of liver function.;Timepoint(s) of evaluation of this end point: 3rd, 14th, 21st, 28th day post-inclusion