Patients with hypoxemic acute respiratory failure due to COVID-19-related pneumonia
Conditions
Interventions
Trade Name: VECTARION INJECTABLE, lyophilisat et solution pour préparation injectable
Product Name: Almitrine (DCI) bis mésilate
Pharmaceutical Form: Lyophilisate for solution for injection
Pharmaceut
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults patients aged 75 years of less - COVID-19 diagnosis in the past 14 days defined as either positive rt-PCR for SARS-cov2 or compatible or lesion in lung in CT (consistent or typical for covid19) or positive serology - Hypoxemic respiratory failure with the following criteria: oxygen saturation level of 92% or less, as measured by pulsed oximetry (SpO2) under oxygen therapy with an oxygen rate of 6 L/min or more. - Hospital admission within 14 days - Patients affiliated to French social security (“AME” excepted) 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 106 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria
Exclusion criteria: - Hypersensitivity to the active substance or to any of the excipients - Pregnancy or breastfeeding woman - Known Hepatic failure (PT 21 µmol/L during hospitalization - Lactate level > 4 mmol/L - Known pulmonary hypertension or right ventricular dysfunction - Diagnosis of pulmonary embolism during the current hospitalization or on-going anticoagulant therapy at curative dose for thromboembolism when hospitalized - PaCO2 of >45 mmHg - Exacerbation of asthma or chronic respiratory failure - Cardiogenic pulmonary edema - Systolic blood pressure of 90 mmHg or less, or use of vasopressor - Urgent need for endotracheal intubation at the discretion of the treating physician - Do-not-intubate order or estimated life expectancy less than 6 months - Participation in another interventional research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 5-day almitrine therapy (2 µg.kg-1.min-1) in reducing the need for mechanical invasive ventilation in patients with hypoxemic respiratory failure due to COVID-19-related pneumonia at seven days;Secondary Objective: To assess the efficacy of intravenous almitrine in reducing: -in-hospital mortality -28-day all-cause mortality -duration of mechanical ventilation -hospitalization rate in the ICU -length of stay in the ICU -hospital length of stay To assess safety and side effects of intravenous almitrine ;Primary end point(s): Endotracheal intubation within 7 days after randomization. Death will be considered as a failure (endotracheal intubation).;Timepoint(s) of evaluation of this end point: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 28-day mortality - In-hospital mortality - Number of ventilator-free days between at day 28 - Number of days in the ICU - Number of days in the hospital - Safety assessment: discontinuation rate of the treatment for arterial lactate more than 4 mmol/L, ALT/AST levels greater then 3 times the upper limit, and diagnosis of pulmonary arterial hypertension or acute cor pulmonale documented by echocardiography;Timepoint(s) of evaluation of this end point: Day 28 | — |
Countries
France
Contacts
Public ContactSophie COURTIAL-DESTEMBERT
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed