Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring moderate to severe ARDS, respiratory failure, rhu-pGSN
Eligibility Criteria
Inclusion Criteria: Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS on CXR or CT, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤200). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 70% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (The ARDS Definition Task Force, 2012), these measures will not be mandated as entry criteria. Age ≥18 years Informed consent obtained from subject/next of kin/legal proxy During the course of the study starting at screening and for at least 6 months after their final study treatment: Female subjects of childbearing potential must agree to use 2 medically accepted/FDA-approved birth control methods Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner All subjects must agree not to donate sperm or eggs Exclusion Criteria: Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload. No clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team Current or planned receipt of extracorporeal membrane oxygenation (ECMO) Pregnant or lactating women Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease Chronic mechanical ventilation or dialysis Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy <6 months unrelated to acute infection in the opinion of the Investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rhu-pGSN Treatment
Normal Saline Placebo
Subjects will receive rhu-pGSN 24 mg/kg once, followed by 5 daily doses of 12 mg/kg based on actual body weight in addition to standard care .
Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care.