Status:
COMPLETED
Efficacy of Intravenous Almitrine in Reducing the Need for Mechanical Ventilation in Patients With Hypoxemic Acute Respiratory Failure Due to Covid-19-related Pneumonia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Covid 19
Hypoxemic Respiratory Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The COVID-19 outbreak is associated with a surge in ICU bed requirement and substantial mortality (estimated between 0.5% and 1%). Admission in the intensive care unit (ICU) and need for mechanical ve...
Eligibility Criteria
Inclusion
- Adults patients aged 80 years or less
- COVID-19 diagnosis defined as either positive RT-PCR for SARS-CoV-2 or COVID-19 compatible or typical chest CT pattern or positive serology for COVID-19 antibodies
- Hypoxemic acute 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 6L/min or more.
- Hospital admission for COVID-19 within 14 days
- Patients affiliated
Exclusion
- Hypersensitivity to the active substance or to any of the excipients
- Pregnancy or breastfeeding woman
- Known Hepatic failure (PT \<50%, Factor V \< 50%)
- Last known Plasma total bilirubin \> 21 μmol/L
- Lactate level \> 4 mmol/L
- ALT and AST levels greater than 3 times the upper limit
- Pulmonary hypertension (PAPs ≥37 mmHG and/or VmaxIT ≥ 2,9 m/s) or right ventricular dysfunction
- History of pulmonary embolism
- Diagnosis of pulmonary embolism during the current hospitalization or on-going anticoagulant therapy at curative dose for thromboembolism when hospitalized
- PaCO2 \> 45 mmHg
- Exacerbation of asthma or chronic respiratory failure
- Cardiogenic pulmonary oedema
- Systolic blood pressure of 90 mmHg or less, or use of vasopressors
- 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
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT04357457
Start Date
September 3 2020
End Date
December 17 2021
Last Update
May 3 2022
Active Locations (1)
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1
Hospital Pitié-Salpêtrière
Paris, France