A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 18
- 主要终点
- Proportion of participants with disease progression from randomization to 28 days post-randomization
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
INB03 + Standard of Care
Patients will receive INB03 + standard medical care
干预措施: INB03 (Drug)
Placebo + Standard of Care
Patients will receive placebo + standard medical care
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with disease progression from randomization to 28 days post-randomization
时间窗: 28 days
Disease progression is defined by the development of need for mechanical ventilation or death. Mechanical ventilation includes CPAP, BIPAP or mechanical ventilation requiring intubation.
次要结局
- Proportion of participants with a new onset embolus or thrombus by Day 28;(28 days)
- Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study;(28 days)
- Length of hospital stay defined as the number of days in hospital from time of randomization to time of discharge or death, whichever occurs first;(28 days)
- Change from baseline in inflammation markers over time.(28 days)
- Proportion of participants with all-cause mortality(28 days)
- Proportion of participants who transfer to ICU level care by Day 28 (ICU level care is defined as a hospital setting where patient to nurse ratio is < 4);(28 days)
- Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28;(28 days)
- Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28;(28 days)
- Proportion of participants who develop a need for renal replacement therapy (defined as need for any type of dialysis including intermittent or continuous peritoneal or hemodialysis) by Day 28;(28 days)