Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 17
- 主要终点
- Number of Serious Adverse Events Relative to Treatment Group
研究概览
简要总结
This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection
详细描述
This Phase II randomized, double-blind, placebo-controlled, study will assess 2 different doses of GLS-1027 in the prevention of severe pneumonitis among those hospitalized with PCR confirmed SARS-CoV-2 infection. Subjects will be randomized at a 1:1:1 ratio to either Standard of Care (SOC) plus placebo, or SOC plus GLS-1027 at either 120 mg or 360 mg daily. Clinical status will be monitored through 56 days from the initiation of treatment.
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)
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
- •Age 18 years or older
- •Able to provide consent
- •Able and willing to comply with study procedures
- •Diagnosis of PCR confirmed SARS-CoV-2
- •Enrollment within 72 of hospitalization
- •WHO COVID-19 classification level 3 or 4
排除标准
- •Pregnant or lactating
- •Need for mechanical ventilation, non-invasive ventilation (NIV), or high-flow O2 (≥60%) via face mask
- •Calculated GFR < 60 (Cockcroft-Gault)
- •Meets treatment algorithm criteria for treatment with a non-study immune modulator
- •Pre-study or planned treatment with a non-study immune modulator
- •Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity
- •Status post transplantation of an organ, bone marrow, or body part
- •Treatment within the past 60 days with a chemotherapeutic agent
- •Diagnosis of leukemia or lymphoma
- •WHO COVID-19 classification level of 5 or greater
- •Unable to take oral medication
- •Grade 3 or greater laboratory abnormalities as characterized by CTCAE v5
研究组 & 干预措施
GLS-1027 120 mg
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
干预措施: GLS-1027 (Drug)
GLS-1027 360 mg
Three 120 mg pills of GLS-1027 given by mouth once daily
干预措施: GLS-1027 (Drug)
Placebo
Three Placebo pills given by mouth once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Serious Adverse Events Relative to Treatment Group
时间窗: 28 days
Number of Treatment Failures at Day 28 From Enrollment
时间窗: 28 days
次要结局
- Assess the Number of Days of Hospitalization Relative to Treatment Group(28 days)
- Assess the Number of Days Requiring ICU Care Relative to Treatment Group(28 days)
- Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group(28 days)
- Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.(28 days)
- Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group(28 days)