A Feasibility Trial Using Trevalan in Healthy Volunteers for Increasing an in Vitro Immune Response to COVID-19 Proteins
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- increase levels of IFNγ
研究概览
简要总结
The gut immune system was shown as an effective target for inducing systemic immune signals against viruses. Oral administration of Travelan, an over the counter product which contains hyperimmune bovine colostrum was shown in preclinical studies to augment the anti-viral immune towards several strains of influenza viruses (RNA viruses).
This study will evaluate the option that Trevalan may help improve the immune system reaction when introduced to COVID-19 proteins in-vitro. 5 healthy volunteers will receive a treatment regimen of 5 days with Trevalan. Before and after treatment, blood samples will be taken in order to test immune response towards viral proteins of the COVID-19 virus in vitro by measuring the number of T cell clone secreting IFNγ against viral antigens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers aged 18 years old and above.
- •No history of drug or alcohol abuse.
- •Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
- •Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Patients must satisfy a medical examiner about their fitness to participate in the study.
- •Patients must provide written informed consent to participate in the study
排除标准
- •Acute illness resulting in emergency department (ED) evaluation or hospitalization in the last 6 month or any acute illness in the last month before enrollment
- •Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease.
- •Chronic drug therapy of any sort
- •Known allergy to milk
- •Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 4 weeks prior to and throughout the duration of the study
- •Participation in another clinical trial within 30 days prior to intervention.
- •Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).
- •Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.
- •Known substance abuse, including inhaled or injected drugs in the year prior to Screening
结局指标
主要结局
increase levels of IFNγ
时间窗: 6 days
The primary objective of this study is to show an increase in levels of IFNγ against viral antigens after treatment regimen with Trevalan
次要结局
- registering adverse events(30 days)
研究者
Assaf Potruch
MD
Hadassah Medical Organization