用口腔鼻管 (BiosimCovex) 预防SARS-CoV-2感染:一个随机,双盲,安慰剂控制的第三阶段研究
Rajesh Shah1, Gitanjali Talele1, Joan Walter2
1Department of Research, Biosimilia Private Limited, Mumbai, India.
Global advances in integrative medicine and health
|October 9, 2025
概括
一种顺势治疗的SARS-CoV-2鼻 (BiosimCovex) 在第三阶段试验中显示出安全性和免疫性. 它在预防COVID-19感染方面表现出有效性,特别是在年轻人和女性中.
科学领域:
- 顺势疗法 顺势疗法 顺势疗法
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
背景情况:
- 研究了一种强化,口服的顺势疗法SARS-CoV-2鼻 (BiosimCovex) 针对COVID-19的安全性,疗效和免疫性.
- 评估了顺势疗法在治疗病毒感染方面的潜力.
研究的目的:
- 为了评估BiosimCovex对SARS-CoV-2感染的安全性,疗效和免疫性.
- 在大型临床试验中确定口服顺势疗法鼻的预防潜力.
主要方法:
- 第三期,多中心,随机,双盲,安慰剂对照试验,共2671名未接种疫苗的参与者.
- 在3天内服用BiosimCovex或安慰剂;通过RT-PCR评估疗效,通过抗体转换评估免疫性,通过症状问卷调查问卷评估安全性.
- 疗效定义为100倍 (1-IRR),在整个60天的研究中监测安全性和疾病负担.
主要成果:
- 在第45天观察到的最大有效率为50.06%,女性 (61.57%) 和18-40岁 (71.88%) 的女性更高.
- 在治疗组中,显著的抗体转化 (48.4% vs 13.4%,P < 0.001) 和症状持续时间缩短 (P = 0.0085).
- 顺势疗法鼻被发现是安全的,轻微的不良事件在没有后果的情况下得到解决.
结论:
- 一种强化口服鼻 (BiosimCovex) 在60天内证明了对SARS-CoV-2感染的安全性,免疫性和预防性疗效.
- 在特定的人口统计数据中,有效性明显更高,这表明有针对性的潜力.
- 这项研究支持对病毒感染的顺势疗法干预措施的调查.
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