A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Determine the Safety and Effectiveness of Azeliragon in the Treatment of Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) or Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Frequency of Adverse Events (AEs) (Phase 2 only)
研究概览
简要总结
A new drug called azeliragon could be used to treat patients with COVID-19 or other pneumonia infections but the researchers don't know. In this study, they are learning the effects of azeliragon patients hospitalized for COVID-19 or pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Azeliragon and placebo will be dispensed and labeled by the unblinded research pharmacist at each site in a blinded manner that will not reveal if the product dispensed is active or placebo.
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
- •Patients with at least two of the following signs or symptoms: cough, chest pain, shortness of breath, hypoxia (oxygen saturation <90%)
- •Clinical diagnosis of pneumonia or COVID-19 during the first 48 hours of hospitalization.
- •Patients admitted to the hospital within the previous 48 hours (from time of admission to initial treatment dose.)
- •Provide informed consent to participate in the study (by participant or legally-acceptable representative).
排除标准
- •Patients for whom intubation within 24 hours of admission is considered likely.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN), OR total serum bilirubin >2x ULN.
- •Patients who were receiving dialysis as a regular treatment at the time of admission. (Participants are not excluded for historic need for dialysis.)
- •Chronic liver disease with Child-Pugh class B of (7 to 9) or higher.
- •Patients with an electrocardiogram (ECG) corrected QT interval (QTc) > 500 ms.
- •Patients requiring treatment with strong inhibitors of CYP2C8
- •Females of childbearing potential who are pregnant, breastfeeding, and/or not using a highly-effective method of contraception (consistent with local regulations regarding the methods of contraception for those participating in clinical studies, including willingness to use 2 acceptable forms of contraception from screening until after the end of drug treatment. Acceptable forms include tubal ligation, male latex condom with or without spermicide, partner's vasectomy, diaphragm with spermicide, intrauterine device, cervical cap/sponge with spermicide, contraceptive sponge, female condom, hormonal contraceptive including oral, transdermal, vaginal ring, subcutaneous injection, or implanted rod.)
- •Allergy to azeliragon or formulation excipients in the azeliragon or placebo capsule.
- •Concurrent participation in another device or drug trial for treatment purposes. Trials with devices intended for diagnostic purposes only are allowable..
- •Any other condition, including abnormal laboratory values that, in the judgment of the investigator, could put the participant at increased risk, or would interfere with the conduct or planned analysis of the study.
研究组 & 干预措施
Phase 2 azeliragon
干预措施: Azeliragon (Drug)
Phase 2 placebo
干预措施: Placebo (Drug)
Phase 3 azeliragon
干预措施: Azeliragon (Drug)
Phase 3 placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of Adverse Events (AEs) (Phase 2 only)
时间窗: Up to 28 days post-treatment
Including overall, treatment-related, Grade 3 or higher in severity, serious AEs (SAEs), fatal, and those resulting in treatment discontinuation
Death, need for mechanical ventilation or Acute Kidney Injury (AKI) of stage 2 or higher per Kidney Disease Improving Global Outcomes (KDIGO) scale (Phase 3 only)
时间窗: Day 14 of hospitalization
The primary outcome is a composite endpoint, which is defined as the need for mechanical ventilation, in-hospital death or AKI of stage 2 or higher per KDIGO scale. There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure). KDIGO Scale definitions: Stage 2 - Serum Creatinine 2-2.9 times baseline Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to ≥4 mg/dL or Initiation of renal replacement therapy
次要结局
- Length of hospitalization (Phase 3 only)(Up to 14 days)
- Frequency of AEs (Phase 3 only)(Day 14 of hospitalization)
- Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)(Day 14 of hospitalization)
- Frequency of sustained renal function (Phase 3 only)(Day 14 of hospitalization)
- Number of days in ICU (Phase 3 only)(Day 14 of hospitalization)
- Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)(Day 14 of hospitalization)
- Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)(Day 14 of hospitalization)