Phase I, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Antiviral Efficacy of Three Different Single Doses of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) in Adult Patients With Mild COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time of viral activity
研究概览
简要总结
This is a randomized, placebo-controlled, double-blind phase I clinical study of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) to evaluate the safety and antiviral efficacy for the treatment of adult patients with mild COVID-19 and low risk of disease 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min.
干预措施: Placebo (Drug)
INOSARS dose 1
Single dose of 5 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
干预措施: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) (Drug)
INOSARS dose 2
Single dose of 15 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
干预措施: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) (Drug)
INOSARS dose 3
Single dose of 30 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
干预措施: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) (Drug)
结局指标
主要结局
Time of viral activity
时间窗: Baseline to 28 days
Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples
Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples
时间窗: Baseline to days 2, 4, 7, 14 and 28
Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples
时间窗: At days 2, 4, 7, 14 and 28
次要结局
- Incidence of anti-INOSARS antibodies(Baseline and day 28)
- Adverse events presented later after infusion(Day 2 until day 28)
- Adverse events presented early after infusion(Baseline to 24 hrs)