EFFICACY OF INTRAVENOUS ALMITRINE IN REDUCING THE NEED FOR MECHANICAL VENTILATION IN PATIENTS WITH HYPOXEMIC ACUTE RESPIRATORY FAILURE DUE TO COVID-19-RELATED PNEUMONIA: A RANDOMIZED CONTROLLED DOUBLE-BLIND STUDYFROM THE SKIP-ICU CONSORTIUM

Phase 1

• Conditions: Patients with hypoxemic acute respiratory failure due to COVID-19-related pneumonia; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001909-22-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-16
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 212

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

-Hypersensitivity to the active substance or to any of the excipients
-Pregnancy or breastfeeding woman
-Known Hepatic failure (PT <50%, Factor V < 50%)
-Known Plasma total bilirubin > 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

Study & Design

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