FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 Pneumonia

Inclusion criteria

• Age ≥ 18 years
• SARS-CoV-2 induced pneumonia confirmed by a positive PCR test in nasopharyngeal swab or respiratory tract secretions and ≤ 85 years
• Acute respiratory distress syndrome (ARDS) according to Berlin criteria (bilateral pulmonary infiltrates on frontal chest x-ray, PaO2/FiO2 ratio ≤300 mmHg, objective assessment excluding hydrostatic pulmonary edema)
• Need for endotracheal intubation and mechanical ventilation
• Informed consent by patient or legal representative. According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed.
• Affiliated to a social security system
• Highly effective method of contraception and negative highly sensitive pregnancy test, for women of childbearing potential

Exclusion criteria

• Mechanically ventilation for more than 4 days
• Patient receiving drugs interfering with inflammation: Non-steroidal anti-inflammatory drugs, immunoglobulins.
• Patients receiving chemotherapy, radiotherapy or immunotherapy for malignancy
• Participation in another interventional clinical trial
• Pregnant or lactating women
• Patient moribund on the day of randomization, defined by a SAPS-II score>90
• Contra-indication for vascular access implantation for transpulmonary thermodilution monitoring
• Severe or terminal renal insufficiency (creatinine clearance <30 ml/min)
• Severe hepatic insufficiency (hepatic SOFA score>2)
• Severe cardiac insufficiency, with left ventricular ejection fraction<30%
• Any history of severe allergic drug reaction (anaphylactic shock or allergic angioedema)
• Persons deprived of their liberty by a judicial or administrative decision (guardianship or tutelage measure)