JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (\<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks). Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival).

All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning. This record only includes information relevant to the vilobelimab cohort.

• ACM at Day 60 and Day 90 [Срок оценки: Day 60 and Day 90]
• ACM+ at Day 28, Day 60, and Day 90 [Срок оценки: Time Frame: Day 28, Day 60, and Day 90]
• Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier) [Срок оценки: Up to and including Day 28 or until Discharge (whichever is earlier)]
• Incidence of new invasive mechanical ventilation use during the study up to and including Day 28 [Срок оценки: Up to and including Day 28]
• Ventilator-free days up to and including Day 28 [Срок оценки: Up to and including Day 28]
• Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90 [Срок оценки: Days 28, 60, and 90]
• Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent [Срок оценки: Up to and including Day 28]
• Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28 [Срок оценки: up to and including Day 28]
• Incidence of participants with new ECMO use during the study up to and including Day 28. [Срок оценки: up to and including Day 28]
• Proportion of participants alive and free of ECMO at Days 28, 60, and 90 [Срок оценки: Days 28, 60, and 90]
• Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8) [Срок оценки: While Hospitalized (up to 90 days)]
• Time to an improvement of one category and two categories from baseline using the WHO 8-levels ordinal scale (from 0-8) at Days 28, 60, and 90 (while hospitalized) [Срок оценки: While Hospitalized (up to 90 days)]