Repurposing Tazemetostat for the Treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 Patient
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Length of hospital stay
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of repurposing tazemetostat for the treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 patients.
详细描述
The investigators hypothesize that tazemetostat will mitigate the hyperinflammatory effects of COVID-19 infection, prevent respiratory deterioration, and reduce requirements of invasive ventilation. This will be conducted as a Phase II open label study. After being informed about the study and potential risks, all patients giving written informed consent will undergo randomization to receive 800 mg tazemetostat BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days, additionally the patients will be evaluated at 30 and 90 days for overall clinical status and sequelae. The study will be conducted at a single site (Loma Linda University Medical Center).
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18-85
- •Diagnosed with q-PCR confirmed infection with SARS-Cov-2 virus and admitted to the hospital.
- •Receiving non-invasive respiratory support through a nasal cannula or a face mask.
- •Ability to take oral medication and be willing to adhere to the tazemetostat regimen.
排除标准
- •Unable to take PO medication.
- •Need for intubation or ECMO.
- •Pregnancy or lactation
- •Known allergic reactions to tazemetostat.
- •Active malignancy (not in remission).
- •Treatment with another investigational drug.
研究组 & 干预措施
Tazemetostat
Subjects will receive tazemetostat 800mg BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days.
干预措施: Tazemetostat (Drug)
结局指标
主要结局
Length of hospital stay
时间窗: Up to one year from date of randomization
Evaluate the effect of tazemetostat treatment of the course of COVID-19 disease by measuring number of days in hospital from time of randomization to date of discharge or in-hospital death from any cause, whichever came first.
次要结局
未报告次要终点