SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
研究概览
简要总结
This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.
详细描述
SARS-CoV-2 infection is associated with excessive inflammation and cytokine storm that can result in lung damage and potentially severe disease. SP16 is an anti-inflammatory and homeostatic drug that rebalances innate immune responses potentially resulting in mitigation of inflammation and lung damage without immunosuppressive effects. SP16's mechanism of action is through targeting LRP1, a receptor that regulates a variety of physiological processes that contribute to inflammation and tissue injury, particularly in the lung. The main objective of this study is to determine the safety and tolerability, and effects on inflammation of SP16 administered subcutaneously at a dose of 6 mg (0.1 mg/kg) or 12 mg (0.2 mg/kg). SP16 has previously been well tolerated in both healthy individuals and heart attack patients at a dose of 0.2 mg/kg. The study will also evaluate improvements in clinical parameters such as patients requiring ventilation, improvement in blood oxygen levels (as defined by both SpO2 > 95% and respiratory rate ≤ 20/minute) and duration of hospitalization or time spent in the Intensive Care Unit (ICU).
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)
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
- •To be considered eligible to participate in this study, the subject must meet all of the Inclusion criteria listed below:
- •Hospitalized patients age ≥ 18 with diagnosis of SARS-CoV-2-infection based on positive
- •PCR test result and can provide informed consent
- •Diagnosed with pneumonia due to SARS-CoV-2
- •Respiratory rate ≥ 25/minute and SpO2 ≤ 93%
- •Review of Chest radiograph, chest computed tomography (CT) scan, or chest ultrasound consistent with bilateral infiltrates.
- •Horowitz index (partial pressure of oxygen/fraction of inspired oxygen [PaO2/FiO2]) ≤
- •If a subject does not have an arterial line in place, a SpO2/FiO2 ≤ 315 may be used.
排除标准
- •To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
- •Age < 18
- •Pregnant or lactating women
- •History of heart failure
- •Clinically significant cardiac dysrhythmia, as determined by investigator
- •History renal impairment
- •Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase
研究组 & 干预措施
Cohort dose 1 of SP16
Patients in cohort 1 (low dose SP16) will receive a single dose of SP16 (0.1 mg/kg or 6 mg) by subcutaneous injection
干预措施: SP16 (6mg) (Drug)
Cohort dose 2 of SP16
Patients in cohort 2 (high dose SP16) will receive a single dose of SP16 (0.2 mg/kg or 12 mg) by subcutaneous injection
干预措施: SP16 (12 mg) (Drug)
Placebo
Patients in placebo arm will receive sterile water by subcutaneous injection.
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
时间窗: Day 1 to 14
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 based on number of adverse events (AEs)
Change in inflammatory cytokines
时间窗: Day 3, Day 6, and Day 14
Subjects' change from baseline in plasma concentrations of inflammatory cytokines (IL-1β, TNF-α, IL-6, and IL-8)
Change in acute phase reactants
时间窗: Day 3, Day 6, and Day 14
Subjects' change from baseline of acute phase reactants (CRP, α-2 macroglobulin, fibrinogen, and D-dimer)
次要结局
- Improvement from baseline in SpO2(Days 3 and 14)
- Proportion of subjects requiring ventilation(Day 14)
- Cumulative days on ventilator(Day 1 to 14)
- Duration of hospitalization(Day 1 to 14)
- Time to clinical improvement(Day 1 to 14)
- Proportion of subjects experiencing TTCI(Day 1 to 14)
- Subjects time to death(Day 1 to 14)
- Change from baseline in Horowitz index(Days 6 and 14)
- Subject's cumulative days in ICU(Day 1 to 14)