A Phase 3 Study to Assess the Safety and Efficacy of Invimestrocel Therapy in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to Pneumonia (REVIVE-ARDS)

未提供0 个研究点目标入组 20 人开始时间: 待定

适应症

试验速览

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•Diagnosis of pneumonia, as determined by the investigator
•Diagnosis of new acute onset moderate to severe ARDS, within the 48 hours prior to planned first dose of IP, as defined by the Berlin criteria, with all of the following criteria confirmed present within the same 24 hour period during screening:
•Receiving invasive mechanical ventilation (IMV) with positive end-expiratory airway pressure (PEEP) >=5cm H2O;
•Bilateral opacities on chest radiograph, computed tomography, or ultrasound;
•Hypoxemic respiratory failure not fully explained by cardiac failure or fluid overload; and,
•Arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2) ratio (PaO2/FiO2) of <200 mmHg (27kPa), and;
•Subject or legally authorized representative (LAR) must provide informed consent after the nature of the study and the disclosure of his/her data has been explained.

•Unable to receive investigational product (IP) within 48 hours of meeting the ARDS diagnosis criteria as defined in inclusion criterion
•The clock starts when the last criterion is met;
•Meet the CDC definition of ventilator-associated pneumonia (VAP);
•Invasive mechanical ventilation for greater than 72 hours prior to fulfillment of ARDS criteria;
•Noninvasive ventilation (NIV) or High-Flow Nasal Cannula (HFNC) and PF<200 (or SPO2/FiO2 <235) for greater than 48 hours prior to IMV

发起方

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