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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Administered as an IV formulation of 800 mg per dose and up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)
Administered as an IV formulation of placebo of up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)
University of Alabama Hospital
Birmingham, Alabama, United States
NOT_YET_RECRUITINGCommunity Regional Medical Center
Fresno, California, United States
RECRUITINGLong Beach Memorial Medical Center
Long Beach, California, United States
RECRUITINGUniversity of California Irvine Medical Center
Orange, California, United States
All-cause mortality (ACM) rate at Day 28
Time frame: Day 28
ACM at Day 60 and Day 90
Time frame: Day 60 and Day 90
ACM+ at Day 28, Day 60, and Day 90
ACM+ composite score will be constructed by combining ACM and participant-relevant, infection-related Adverse Events (AE) and Serious Adverse Events (SAEs) from the MedDRA toxic/septic shock standardized MedDRA queries (SMQ).
Time frame: Time Frame: Day 28, Day 60, and Day 90
Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)
Time frame: Up to and including Day 28 or until Discharge (whichever is earlier)
Incidence of new invasive mechanical ventilation use during the study up to and including Day 28
Time frame: Up to and including Day 28
Ventilator-free days up to and including Day 28
Time frame: Up to and including Day 28
Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90
Time frame: Days 28, 60, and 90
Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent
Time frame: Up to and including Day 28
Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28
Time frame: up to and including Day 28
Incidence of participants with new ECMO use during the study up to and including Day 28.
Time frame: up to and including Day 28
Proportion of participants alive and free of ECMO at Days 28, 60, and 90
Time frame: Days 28, 60, and 90
Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8)
Time frame: While Hospitalized (up to 90 days)
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)
Time frame: While Hospitalized (up to 90 days)
Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)
Time frame: While Hospitalized (up to 90 days)
Proportion of participants who improve clinical status as measured by the Karnofsky scale
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.
Time frame: Post hospitalization through Day 90
Days of hospitalization up to and including Day 28
Time frame: up to and including Day 28
Days of ICU stay up to and including Day 28
Time frame: up to and including Day 28
Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90
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.
Time frame: from hospital discharge to Day 60 and to Day 90
Change in St. George's Respiratory Questionnaire (SGRQ) from hospital discharge to Day 60 and to Day 90
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.
Time frame: From hospital discharge to Day 60 and to Day 90
Incidence and severity of adverse events (AEs) /adverse event of special interest (AESI) / serious adverse event (SAEs)
Time frame: Through Day 90
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University of California Davis Medical Center - Pulmonary Medicine
Sacramento, California, United States
RECRUITINGStanford Medical Center
Stanford, California, United States
RECRUITINGDenver Health Hospital and Authority
Denver, Colorado, United States
RECRUITINGMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGNova Clinical Research
Bradenton, Florida, United States
RECRUITINGNorth Florida / South Georgia Veterans Health System
Gainesville, Florida, United States
RECRUITING...and 31 more locations