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 B: Participants will be randomized to receive either a placebo or paridiprubart.

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

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Acute Respiratory Distress Syndrome (ARDS)

ARDS

ARDS (Acute Respiratory Distress Syndrome)

Acute Respiratory Distress Syndrome

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 paridiprubart cohort.

Cohort B: paridiprubart

Cohort B: placebo

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

ACM+ composite score will be constructed by combining ACM and participant-relevant, infection-related Adverse Events (AE) from the MedDRA toxic/septic shock standardized MedDRA queries.

The Karnofsky scale is used to assess the general condition of the patient. Scores range from 0 to 100 with higher scores indicating better functional ability.

The SF-12 is a self-reported outcome measure composed by 12 items which examine eight dimensions of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores range between 0 and 100 with higher scores indicating more limitations.

University of Alabama Hospital

Community Regional Medical Center

Long Beach Memorial Medical Center

University of California Irvine Medical Center

University of California Davis Medical Center - Pulmonary Medicine

Denver Health Hospital and Authority

MedStar Washington Hospital Center

Nova Clinical Research

North Florida / South Georgia Veterans Health System

Sarasota Memorial Hospital

St. Luke's Boise Medical Center

Northshore University Healthsystem Research Institute

OSF Saint Francis Medical Center-

Tufts Medical Center

Lahey Hospital and Medical Center

University of Michigan Hospital

Henry Ford Health Hospital

Mayo Clinic

Renown Institute for Heart & Vascular Health

Robert Wood Johnson Medical School

Memorial Sloan Kettering Cancer Center

Montefiore Hospital - Moses Campus

University of North Carolina at Chapel Hill

Durham VA Medical Center

University Hospitals Cleveland Medical Center

Cleveland Clinic

Mercy Health - St. Vincent Medical Center

The University of Oklahoma Health Sciences Center

Oregon Health and Science University

Medical University of South Carolina (MUSC)

Vanderbilt University Medical Center

Baylor All Saints Medical Center

Houston Methodist Hospital

Intermountain Medical Center

University of Virginia Health System

Swedish Medical Center

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?