Treatment of Acute Respiratory Syndrome Resulting From the Inflammatory Process of COVID-19 Infection Using Methotrexate-loaded Nanoparticles: A Phase I/II Study
试验速览
- 阶段
- 1 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in clinical conditions
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of MTX-loaded nanoparticles in three different doses to treat severe COVID-19 patients.
详细描述
Patients with acute lung injury caused by COVID-19 disease are experiencing an inflammatory reaction that can be harmful and worsen the severity of the clinical condition. Thus, the use of MTX-loaded nanoparticules in patients with acute lung injury secondary to COVID-19 aims to decrease the exacerbated inflammatory reaction leading to a decrease in cell damage caused by this inflammatory process in patients.
The study will be divided in 3 phases:
Phase A (n=4): IV administration of 20 mg of MTX-loaded nanoparticles. Four doses of Investigational Product (IP) will be administered, once per week. If patients show clinical improvement after 2nd or 3rd administration, the next phase will start.
Phase B (n=12): IV administration of 30 mg of MTX-loaded nanoparticles. Four doses of Investigational Product (IP) will be administered, once per week. If patients show clinical improvement after 2nd or 3rd administration, the next phase will start.
Fase C (n=26): IV administration of 40 mg of MTX-loaded nanoparticules. Four doses of Investigational Product (IP) will be administered, once per week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Informed consent from patient or legal representative.
- •Male or female, aged ≥ 18 years;
- •Acute respiratory distress syndrome; with imminent risk of death, and with chest CT scan with pulmonary impairment greater than 50%;
- •Confirmed or pending diagnosis of COVID-19.
排除标准
- •Pleural effusion > 150mL or ascites > 200mL;
- •Chronic liver disease;
- •ALT and AST serum levels >= three times the upper limit of normality;
- •Renal failure (dialysis)
- •Multiple organ failure
- •Concomitant use or use in the last 7 days of cell therapy with stem cells;
- •Any clinical or laboratory condition or comorbidity that, at medical discretion,
- •Known hypersensitivity to the investigational product;
- •Subject who is pregnant or lactating
研究组 & 干预措施
A
Phase A: subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
干预措施: Methotrexate (Drug)
B
Phase B: will only start after 2nd or 3rd administration of phase A. Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).
干预措施: Methotrexate (Drug)
C
Phase C: will only start after 2nd or 3rd administration of phase B. Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change in clinical conditions
时间窗: 21 days
Clinical condition will be measured by lung injuries
次要结局
- Changes of blood oxygen(21 days)
- ICU discharge(21 days)
- Rate of mortality(4 months)
- Hypoxia(21 days)
- Hospital discharge(21 dyas)
- Change of Clinical symptoms - respiratory rate(21 days)
- Evolution of Acute Respiratory Syndrome(21 days)
- Inflammatory parameters(21 days)