Clinical trial NCT06701682: JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
Official title: Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome (ARDS)
ARDS
ARDS (Acute Respiratory Distress Syndrome)
Acute Respiratory Distress Syndrome
Keywords: BARDA
JUST BREATHE
ARDS
Acute Respiratory Distress Syndrome
Acute Respiratory Failure
Lead sponsor: PPD Development, LP
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
name: InflaRx GmbH
name: Edesa Biotech Inc.
name: Genentech, Inc.
First posted: 2024-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.

Cohort A: Participants will be randomized to receive either a placebo or vilobelimab.

This record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

* ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization

Exclusion Criteria:

* No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.

Primary outcomes:
measure: All-cause mortality (ACM) rate at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: ACM at Day 60 and Day 90
timeFrame: Day 60 and Day 90
measure: ACM+ at Day 28, Day 60, and Day 90
timeFrame: Time Frame: Day 28, Day 60, and Day 90
measure: Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)
timeFrame: Up to and including Day 28 or until Discharge (whichever is earlier)
measure: Incidence of new invasive mechanical ventilation use during the study up to and including Day 28
timeFrame: Up to and including Day 28
measure: Ventilator-free days up to and including Day 28
timeFrame: Up to and including Day 28
measure: Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90
timeFrame: Days 28, 60, and 90
measure: Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent
timeFrame: Up to and including Day 28
measure: Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28
timeFrame: up to and including Day 28
measure: Incidence of participants with new ECMO use during the study up to and including Day 28.
timeFrame: up to and including Day 28
measure: Proportion of participants alive and free of ECMO at Days 28, 60, and 90
timeFrame: Days 28, 60, and 90
measure: Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8)
timeFrame: While Hospitalized (up to 90 days)
measure: 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)
timeFrame: While Hospitalized (up to 90 days)
measure: Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)
timeFrame: While Hospitalized (up to 90 days)
measure: Proportion of participants who improve clinical status as measured by the Karnofsky scale
timeFrame: Post hospitalization through Day 90
measure: Days of hospitalization up to and including Day 28
timeFrame: up to and including Day 28
measure: Days of ICU stay up to and including Day 28
timeFrame: up to and including Day 28
measure: Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90
timeFrame: from hospital discharge to Day 60 and to Day 90
measure: Change in St. George's Respiratory Questionnaire (SGRQ) from hospital discharge to Day 60 and to Day 90
timeFrame: From hospital discharge to Day 60 and to Day 90
measure: Incidence and severity of adverse events (AEs) /adverse event of special interest (AESI) / serious adverse event (SAEs)
timeFrame: Through Day 90
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Nova Clinical Research
state: Florida
city: Boise
country: United States
facility: St. Luke's Boise Medical Center
state: Idaho
city: Reno
country: United States
facility: Renown Institute for Heart & Vascular Health
state: Nevada
city: Bronx
country: United States
facility: Montefiore Hospital - Moses Campus
state: New York
Study officials:
References: