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 - AIRVM COVID

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 212 人开始时间: 2020年4月16日最近更新: 2020年5月11日

适应症

试验速览

暂无简介。

•-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

•-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

发起方