A prospective open label clinical trial to evaluate the topical viral load reduction potential of PROTECT-C hand sanitizer on SARS-CoV-2 infected subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinically significant Quantitative Reduction of
研究概览
简要总结
This new innovation works by destroying the virus with a unique Oxidation mechanism. This solution when sprayed gets activated on contact with air, providing a timely, powerful anti-bacterial oxidizing effect. The sterilizing mechanism generates reactive oxygen on contact with Viruses, Bacteria, and Fungi in the air or on objects, altering and destroying the virus.
This is the background behind the research and innovation of the solution, with a brand name, PROTECT-C.
PROTECT-C works by timely releasing chlorine dioxide solution, which sterilizes the virus and bacteria, through the action of an oxidation reaction, resulting in total annihilation of the virus. While the other standard sanitizing solutions available in the world today, use chlorine ions, which tend to release Chlorine gas, which is harmful to normal human cells and organs. Hence PROTECT-C has the potential to be used as a sanitizer in Covid 19.
The current research is a validation of the potential of PROTECT C in covid 19 as a hand sanitizer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Tested SARS- CoV-2 positive within last 8 days of study enrolment.
- •Patients willing to sign written informed consent and are ready to comply to study procedure.
- •SARS-CoV-2 positive asymptomatic or symptomatic patients who are under institutional quarantine/ home isolated/ hospitalized.
排除标准
- •Patients on ventilator support.
- •Pregnant or lactating woman.
- •Subjects with history of sun burn on hands.
- •Subjects with history of skin disorders or on medication for the same: Eczema, Urticaria, Psoriasis, Herpes, skin cancer, Lupus, Vitiligo, Fungal infection, Candidiasis.
- •Subjects on treatment of any degree burns.
- •Any kind of psychiatric disorder or a condition in the opinion of the investigator may hinder communication with the research team.
- •Inability of the subject to cooperate or communicate with the research team and provide follow up.
结局指标
主要结局
Clinically significant Quantitative Reduction of
时间窗: 90 sec
80% Virus load from baseline to EOT.
时间窗: 90 sec
次要结局
- Tolerability and safety of intervention(90 sec)