NCT04370236终止2 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 9
- 主要终点
- Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression
研究概览
简要总结
The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
详细描述
The trial is a Phase 2, double-blind, randomized, placebo-controlled clinical trial of INB03 in participants with pulmonary complications due to COVID-19 infection.
Patients with COVID-19 infection and low blood oxygen levels with at least one high risk factor (see below) are eligible to participate in a 40-day study to determine whether INB03 can prevent the progression of pulmonary complications.
Eligible participants will be randomized (1:1) to receive either INB03 + standard of care (SOC) or Placebo + SOC. Participants randomized to INB03 + SOC will receive a 1mg/kg injection of INB03 after randomization. Patients that remain in the hospital 7 days after the first dose will receive a second dose. A final safety visit will occur on Day 70.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have one or more of the following comorbidities:
- •Age ≥ 65 years;
- •Obesity (BMI ≥ 30);
- •Hypertension (on one or more drugs for treatment of hypertension);
- •Diabetes (on one or more drugs for Type I or Type II diabetes);
- •Cardiovascular disease (on one or more drugs for treatment of cardiovascular disease, other than aspirin);
- •History of congestive heart failure (CHF) or myocardial infarction (MI);
- •Black or African-American race (at least one parent identifies as Black or African-American);
- •Hispanic or Latino ethnicity.
- •Have a positive COVID-19 test in the last 28 days;
- •Have room air SaO2 < 96%, or SpO2 < 96% on room air at sea level, or PaO2/FiO2 < 300;
- •Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;
- •Provide written informed consent prior to any study related procedures being performed.
排除标准
- •Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening:
- •Age < 18 years;
- •Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP);
- •Require immediate admission to an Intensive Care Unit (ICU) for any reason;
- •On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months;
- •Being treated with dexamethasone (IV or PO) at a dose of >15mg per day or solumedrol or equivalent corticosteroid at a dose of >75mg per day;
- •Taking any medication known to be CCR5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months;
- •Taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months;
- •Known to be pregnant;
- •Has known HIV, HCV or HBV infection;
- •Has known Mycobacterium tuberculosis infection or evidence of infection on chest X-ray;
- •Significant hepatic disease (ALT/AST> 4 times the ULN);
- •On therapy for cancer in the last 6 months;
- •On therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason;
- •Known hypersensitivity to investigational product or its excipients;
- •Participating in an investigational drug or device trial;
- •Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.
研究组 & 干预措施
Placebo + Standard of Care
Placebo Comparator
Patients will receive placebo + standard medical care
干预措施: Placebo (Drug)
INB03 + Standard of Care
Experimental
Patients will receive INB03 + standard medical care
干预措施: INB03 (Drug)
结局指标
主要结局
Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression
时间窗: 28 days
Primary Endpoint: Cochran-Mantel-Haenszel Analysis of Proportion of Patients with Disease Progression (mITT Population)
次要结局
- Proportion of Patients With All-cause Mortality(Through study completion which could be up to Day 70)
- Proportion Transferred to ICU Level Care by Day 28(Randomization to Day 28)
- Proportion With New Onset of Neurologic Disease by Day 28(Randomization to Day 28)
- Proportion With Evidence of New CHF or New MI Requiring Medical Intervention by Day 28(Randomization to Day 28)
- Proportion With New Onset Embolus or Thrombus by Day 28(Randomization to Day 28)
- Proportion Developing a Need for Renal Replacement Therapy by Day 28(Randomization to Day 28)
- Proportion With an Increase in the WHO Ordinal Scale of Clinical Improvement Score at Any Time During the Study(Through study completion, which could be up to Day 70)
- Length of Hospital Stay(Randomization to time of discharge or death, whichever occurs firts)
- Change From Baseline in Inflammation Markers Over Time - Troponin I(Baseline to Day 40)
- Change From Baseline in Inflammation Markers Over Time - Glomerular Filtration Rate(Baseline to Day 40)
- Change From Baseline in Inflammation Markers Over Time - Ferritin(Baseline to Day 40)
- Change From Baseline in Inflammation Markers Over Time - D-Dimer(Baseline to Day 40)
- Change From Baseline in Inflammation Markers Over Time - CRP(Baseline to Day 40)
研究者
研究点 (9)
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