A Two-part, Two-cohort, Double-blind, Randomized, Placebo-controlled, Multicenter Phase 1/2 Study to Evaluate the Safety, Tolerability and Efficacy of REJUVEINIX (RJX) in Patients With COVID-19
试验速览
- 阶段
- 1 期
- 入组人数
- 237
- 试验地点
- 3
- 主要终点
- Tolerability and Efficacy measured by progression of disease through an ordinal scale.
研究概览
简要总结
This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in patients with COVID-19.
详细描述
For each cohort, there will be an open label Safety Lead-in (Part 1) and a placebo controlled, randomized, double-blind portion (Part 2). In Part 1, RJX will be administered daily for 7 days. In the active treatment arm of Part 2 for both cohorts, RJX will be administered daily for 7 days per cycle and patients may receive up to 2 cycles. As detailed below, patients will be allowed to receive a second 7 day cycle of therapy based on the medical judgment of the Investigator. The total RJX exposure during Part 2 could therefore be up to 14 days. Both cohorts will start and enroll in parallel and independently. A safety follow-up period will begin at Day 14/Discharge, or when treatment is discontinued, and will continue for approximately 60 days post discharge. Part 1 will be conducted at a single site and Part 2 will be conducted at multiple sites. The 2 cohorts in this study are:
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Cohort 1:
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Hospitalized COVID-19 patients ≥18 years without hypoxemia who are either not receiving any oxygen therapy OR are receiving supplemental oxygen via mask or nasal prongs (namely, clinical status score 4 or 5 on an 8-point ordinal scale).
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Patients are required to have the following high-risk characteristics
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Age ≥65 years AND type 2 diabetes or hypertension OR
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Age ≥18 years with abnormal blood tests AND CRP >50 mg/L PLUS at least 1 of the following biomarkers:
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D-dimer >1,000 ng/mL,
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Ferritin >500 µg/L,
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High sensitivity cardiac troponin >2 × upper limit of normal (ULN),
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LDH >245 U/L.
- Cohort 2:
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
- Double (Participant, Investigator)
盲法说明
Masking the dose administered
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
Arm A: RJX
- RJX 20 mL (10 mL of Vial A plus 10 mL of Vial B) mixed in normal saline, total volume 120 mL, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily.
- Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment).
- Patients in Part 1 are allowed to receive only one 7-day cycle of RJX while patients in Part 2 may be treated daily for up to 14 days.
干预措施: Rejuveinix (RJX) Active Comparator (Drug)
Arm B: Placebo
- Placebo (total of 20 mL normal saline) mixed in normal saline IV, total volume 120 mL of normal saline IV, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily.
- Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment).
- Patients in Part 1 will not receive placebo.
- Patients in Part 2 may be treated daily for up to 14 days.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Tolerability and Efficacy measured by progression of disease through an ordinal scale.
时间窗: Within 2 weeks
• Part 2, Cohort 1: Progression to severe disease on an 8-point ordinal scale from a clinical status score of 4 or 5 to a clinical status score of 3, 2, or 1 within 2 weeks of first dose of study drug
Safety as measured by DLTs and drug related SAE's
时间窗: Up to 60 days post-enrollment
• Part 1, Cohorts 1 and 2: Cumulative incidence of DLTs and drug-related SAEs (viz., sum of DLT + SAEs) reported within 14 days of first dose of RJX (Part 1) or reported within 60 days of first dose of study drug (Part 2)
Efficacy measured by time to resolution of respiratory failure
时间窗: 60-days post enrollment
• Part 2, Cohort 2: Time to resolution of respiratory failure (TTRRF), with status change on an 8-point ordinal scale from a clinical status score of 3 to a clinical status score of ≥4
次要结局
- Efficacy measured by mean change in baseline clinical status on Days 7 and 14.(14-days post enrollment)
- Efficacy as measured by day of ICU care.(60-days post enrollment)
- Efficacy measured by time to coming off supplemental oxygen on Days 7 and 14.(14-days post enrollment)
- Safety, Tolerability, Efficacy measured by mortality over 28 Days.(28-days post enrollment)
- Safety and Efficacy measured by time from first dose to renal therapy.(60-days post enrollment)
- Efficacy measured by mean change in hospitalization days on Days 7 and 14.(14-days post enrollment)