Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 62
- 主要终点
- All-cause mortality (ACM) rate at Day 28
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The overall 2-step randomization scheme will be implemented.
- Randomization Level 1 will be open-label, assigning an eligible patient to one of the available treatment cohorts.
- Randomization Level 2 will be double-blinded and will randomize participants at a 1:1 ratio to receive either IP or placebo within a specific cohort. Thus, the PPD blinded team, site blinded staff members, and participants/legal authorized representative will be considered blinded to study treatment assignment (either IP or placebo) throughout the course of the study.
To preserve the integrity of the study blind, an unblinded pharmacist at each site will be responsible for the reconstitution and dispensation of all study drugs and placebos and will endeavor to ensure that there are no observable differences between the treatment groups (IP or placebo) when dispensing the study materials.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following inclusion criteria are in addition to the
排除标准
- •specified in the Master Protocol NCT
- •ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
- •Exclusion Criteria:
- •The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT
- •Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater
研究组 & 干预措施
Cohort A: placebo
干预措施: Cohort A: placebo (Drug)
Cohort A: vilobelimab
干预措施: Cohort A: vilobelimab (Drug)
结局指标
主要结局
All-cause mortality (ACM) rate at Day 28
时间窗: Day 28
次要结局
- Incidence of new invasive mechanical ventilation use during the study up to and including Day 28(Up to and including Day 28)
- Ventilator-free days up to and including Day 28(Up to and including Day 28)
- ACM at Day 60 and Day 90(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)(Up to and including Day 28 or until Discharge (whichever is earlier))
- Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90(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(Up to and including Day 28)
- Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28(up to and including Day 28)
- Incidence of participants with new ECMO use during the study up to and including Day 28.(up to and including Day 28)
- Proportion of participants alive and free of ECMO at Days 28, 60, and 90(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)(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)(While Hospitalized (up to 90 days))
- Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)(While Hospitalized (up to 90 days))
- Proportion of participants who improve clinical status as measured by the Karnofsky scale(Post hospitalization through Day 90)
- Days of hospitalization up to and including Day 28(up to and including Day 28)
- Days of ICU stay up to and including Day 28(up to and including Day 28)
- Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90(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(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)(Through Day 90)
- ACM+ at Day 28, Day 60, and Day 90(Time Frame: Day 28, Day 60, and Day 90)