NCT06857318已完成1 期
Colostrum from MERS-CoV Seropositive Camels for SARS-CoV-2 Infection - from Lab to Human- a Placebo Controlled Randomized Trial.
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Viral Load and Infectivity
研究概览
简要总结
The study aims to study the efficacy of colostrum from MERS-CoV-positive camels applied as a nasal spray to COVID-19 patients for treatment and prevention of SARS-CoV-2 infection. This study will compare the usage of colostrum to placebo.
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
- •Age over 18 years.
- •Laboratory-proven infection with COVID-19 using PCR or another approved kit
- •Hospitalized / community setting-at low-moderate clinical risk according to the NEWS-2 scale with a score of 0-
- •Onset of symptoms up to 7 days before inclusion
- •Can sign informed consent
- •Willingness and ability to participate in research
排除标准
- •Pregnant women or lactating
- •Lack of judgment (psychiatric disorder or dementia)
- •Immunosuppressed - HIV with CD4 below 500, chemotherapy, steroids - more than 5 mg per day, solid organ transplants, bone marrow transplants, active hematological or oncological malignancies, biological therapy
- •Neutropenia (less than 2000 neutrophils per cubic meter) or thrombocytopenia (platelet count less than 50000 per cubic meter).
- •Acute or chronic sinusitis.
- •Nasal polyps or any pathology in the nasal cavity
- •Cystic fibrosis
- •Significant disturbance in liver functions (AST/ALT more than 5 times the ULN)
- •Significant renal dysfunction (GFR lower than 30 ml per minute)
- •Known allergy to colostrum or cow's milk
- •Use of another study drug
研究组 & 干预措施
Colostrum Treatment Group
Experimental
干预措施: Colostrum Nasal Spray (Biological)
Control
Placebo Comparator
干预措施: Water for injection (Other)
结局指标
主要结局
Viral Load and Infectivity
时间窗: 24 hours
Viral load and infectivity will be measured using nasal swabs
次要结局
- Undetectable Viral Load and Non-infectious Virus(72 hours)
研究者
Hila Elinav
Director of Hadassah AIDS center
Hadassah Medical Organization
研究点 (1)
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