Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Launched by BIOAEGIS THERAPEUTICS INC. · Jul 9, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called rhu-pGSN for patients with Acute Respiratory Distress Syndrome (ARDS) caused by infections like pneumonia. The study aims to see how effective and safe this treatment is compared to a placebo, which is a substance with no active medication. Eligible participants are adults aged 18 and older who have been diagnosed with moderate-to-severe ARDS within 48 hours of showing signs of infection. They must be receiving respiratory support, such as mechanical ventilation or high-flow oxygen.

Participants in the trial will be randomly assigned to receive either the new treatment or a placebo, in addition to the standard care they would usually receive in the hospital. Before enrolling, potential participants will need to provide informed consent, and certain health conditions will be screened to ensure safety. It's important to note that women who can become pregnant and men with female partners must agree to use reliable birth control methods during the study. This trial is currently recruiting participants, and those who join will help researchers understand whether rhu-pGSN can improve outcomes for patients suffering from this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist
• • Investigator or designee to note radiologic findings in the electronic case report form (eCRF)
• • Radiology report and conclusion should be summarized in the eCRF
• • A digital copy of the radiograph uploaded and saved for review
• • 2. 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 ≤150). 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 50% 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 (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.
• • 3. Age ≥18 years
• • 4. Informed consent obtained from subject/next of kin/legal proxy
• • 5. 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
• 6. During the course of the study starting at screening and for at least 3 months after their final study treatment:
• • 1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods
• • 2. 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
• • 3. All subjects must agree not to donate sperm or eggs
• Exclusion Criteria:
• • 1. 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.
• • 2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection
• • 3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO)
• • 4. Pregnant or lactating women
• • 5. Previous splenectomy
• • 6. Any vaccination in the previous 30 days
• • 7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days
• • 8. Known allergy to study drug or excipients
• • 9. Weight \>125 kg
• • 10. 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
• • 11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease
• • 12. Chronic mechanical ventilation or dialysis
• • 13. 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.