A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- 28 day all-cause mortality will be a primary end point for Phase 1 and 2
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients.
详细描述
The primary objective of the study is to evaluate the safety and tolerability of a single dose of AVM0703 in patients with moderate, severe or immediately life-threatening ARDS due to COVID-19 or Influenza (A or B) infection.
The secondary objectives of the study are to 1) evaluate the pharmacokinetics (PK) and 2) evaluate potential clinical findings following a single dose of AVM0703.
The exploratory objective of the study is to assess potential biomarkers indicative of natural killer T (NKT) cell activity and biomarkers predictive of response to AVM0703 in peripheral blood and bronchoalveolar lavage.
The results of the Phase 1 study will guide the design of the Phase 2 study.
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 pharmacist will prepare the infusion solution and medication for delivery to the patient's bedside for administration. The active and placebo medications look identical, preventing care-givers and the participant from breaking the blind.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AVM0703 COVID-19 ARDS - active
Supra-pharmacologic dexamethasone sodium phosphate
干预措施: AVM0703 (Drug)
Placebo COVID-19 ARDS - placebo
Matching placebo
干预措施: Placebo (Drug)
AVM0703 Influenza ARDS - active
Supra-pharmacologic dexamethasone sodium phosphate
干预措施: AVM0703 (Drug)
AVM0703 Influenza ARDS - placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
28 day all-cause mortality will be a primary end point for Phase 1 and 2
时间窗: 0-12 months
The primary endpoint of the Phase 1/2 portion of the study is to evaluate the efficacy of AVM0703 in subjects with severe or life-threatening COVID-19 infection.
Dose-Limiting Toxicities
时间窗: 0-12 months
The primary endpoint of the Phase 1 portion of the study is to evaluate the safety of AVM0703 in subjects with severe or life-threatening COVID-19 infection, and to identify the RP2D.
次要结局
未报告次要终点