A Phase 2, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- Evaluate the Effect of RBT-9 Versus Placebo on Clinical Status of COVID-19 Patients as Measured Using the 8-point World Health Organization (WHO) Ordinal Clinical Scale
研究概览
简要总结
The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 versus placebo in coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥18 years of age at Screening.
- •Confirmed infection with SARS-CoV-
- •High risk of COVID-19 disease progression, defined as:
- •18-69 years of age with lymphopenia AND 1 additional risk factor (described below)
- •18-69 years of age without lymphopenia AND 2 risk factors (described below)
- •≥70 years of age with lymphopenia OR 1 other risk factor (described below)
- •Risk Factors:
- •Documented history of coronary artery disease
- •Heart failure (New York Heart Association Class 3 or 4)
- •Chronic lung disease (eg, asthma or chronic obstructive pulmonary disease) requiring treatment
- •Documented history of stroke
- •Diabetes mellitus, requiring at least 1 prescription medicine for management
- •Documented chronic kidney disease with an estimated glomerular filtration rate <30 mL/min, not on dialysis
- •Obesity (Class 2 or 3; body mass index >34.9 kg/m2)
- •On immunosuppressive therapy
- •Oxygen saturation between 90 and 95% with or without supplemental oxygen
- •Admitted to a hospital for observation and/or treatment (controlled facility may include an emergency room, urgent care facility, temporary/modular hospital, infusion center, clinical research unit, etc).
- •If female, must be postmenopausal, surgically sterile, or if of childbearing potential, must be practicing 2 effective methods of birth control during the study and through 30 days after completion of the study.
- •For females of childbearing potential, a urine pregnancy test must be negative at the Screening Visit.
- •If male, must be surgically sterile or willing to practice 2 effective methods of birth control during the study and through 30 days after completion of the study.
- •Must be willing and able to give informed consent and comply with all study procedures.
排除标准
- •Anticipated need for ICU care and/or ventilatory support (invasive or noninvasive) within 24 hours.
- •Evidence of acute cardiac injury, as determined by the Investigator at the time of Screening. This may be based upon clinical signs and symptoms, ECG findings, or elevated troponin I levels.
- •Evidence of acute kidney injury not due to pre-renal azotemia or urinary tract obstruction at the time of Screening.
- •Oxygen saturation <90% on supplemental oxygen with a nasal cannula, including high-flow oxygen at the time of Screening.
- •Requires non-invasive ventilation at the time of Screening.
- •Requires dialysis at the time of Screening.
- •Has received or is receiving anti-IL-6 therapies (eg, Tocilizumab, Sarilumab, Siltuximab, etc) for the treatment of COVID-19; subjects receiving anti-IL-6 therapies for underlying medical conditions unrelated to COVID-19 are not excluded from eligibility.
- •Pregnant or lactating.
- •History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-
- •Known hypersensitivity or previous anaphylaxis to RBT-9 (stannous protoporphyrin) or any tin-based product.
- •Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug.
- •Inability to comply with the requirements of the study protocol.
研究组 & 干预措施
RBT-9 (90 mg)
RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1.
干预措施: RBT-9 (90 mg) (Drug)
Placebo
0.9% sodium chloride (normal saline) will be administered intravenously over a 120-minute period on Day 1.
干预措施: 0.9% sodium chloride (normal saline) (Drug)
结局指标
主要结局
Evaluate the Effect of RBT-9 Versus Placebo on Clinical Status of COVID-19 Patients as Measured Using the 8-point World Health Organization (WHO) Ordinal Clinical Scale
时间窗: baseline and 7 days, baseline and 28 days
Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale which measures the clinical status of a subject at the first assessment of a given day with category 1, most favorable, and category 8, least favorable (1. Ambulatory, no limitation of activities; 2. Ambulatory, limitation of activities; 3. Hospitalized, no oxygen therapy; 4. Hospitalized, oxygen by mask or nasal prongs; 5. Hospitalized, non-invasive ventilation or high-flow oxygen; 6. Hospitalized, intubation and mechanical ventilation; 7. Hospitalized, ventilation plus additional organ support - pressors, renal replacement therapy \[RRT\], extracorporeal membrane oxygenation \[ECMO\]; 8. Death)
次要结局
未报告次要终点