EUCTR2020-004137-21-NL进行中（未招募）1 期
Effect of intranasal administration of palivizumab on experimental respiratory syncytial viral infection – a human challenge study - CHIMP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Healthy males or females
- •2.Age 18-55 years
- •3.Signed and dated informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Child < 3 years old living in subject’s household
- •2. Person > 65 years old or significant primary or secondary immunodeficiency living in subject’s household
- •3. Presence of significant acute or chronic medical illness that is associated with increased risk of respiratory viral illness related complications. These include but are not limited to:
- •a. Recent (within adulthood) history of asthma, chronic obstructive pulmonary disease (COPD), hypertension, reactive airway disease, or any other chronic lung illness
- •b. History or evidence of impaired immune responsivity or autoimmune disease
- •c. Confirmed hepatitis B (HBV), human immunodeficiency virus (HIV), or hepatitis C (HCV) infection
- •4. Adults with a nasal cold or obstructions which could interfere with administration of the study intervention
- •5. Simultaneous use of other nasal drops, sprays, or medications
- •6. Nasal surgery prior to or during the trial
- •7. COVID-19 infection 48 hours before study start
- •8. Pregnancy
- •9. Symptoms of clear nasal congestion
研究者
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