Health TrialsbyHealthPanel

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

ConditionsAcute Respiratory Distress SyndromeInfections
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioAegis Therapeutics Inc.

About this trial

BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Presence of systemic fungal, yeast, parasitic, or mycobacterial infection

Current or planned receipt of extracorporeal membrane oxygenation (ECMO)

Pregnant or lactating women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rhu-pGSN

    Drug

    Intravenous administration based on actual body weight

  • normal saline

    Drug

    intravenous administration in the same volume as the active therapy

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Rhu-pGSN TreatmentExperimental treatment 1 intervention
Group B: Normal Saline PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality at day 28

Death for any reason through Day 28 between treatment groups

Time frame
28 days

Secondary outcomes

1

Ventilator-free days

Ventilator-free days through Day 28 between treatment groups

Time frame
28 days
2

All-cause mortality at day 60

Death for any reason through Day 60 between treatment groups

Time frame
60 days
3

Proportion of surviving subjects without respiratory support

Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups

Time frame
28 days
4

Time to death and proportions of subjects dying over time

Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioAegis Therapeutics Inc.

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Source ClinicalTrials.gov
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