The Negativisation Rate of Positive PCR Swab Tests for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Treatment With Hydrogen Peroxide: a Double-blind Placebo-controlled Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The negativisation rate of a positive SARS-CoV-2 (COVID-19) PCR nose swab test
研究概览
简要总结
Hydrogen peroxide is produced physiologically by oral bacteria and plays a significant role in the balance of oral microecology since it is an important antimicrobial agent. In the epithelial cells, the enzyme superoxide dismutase catalyzes a reaction leading from hydrogen peroxide to the ion superoxide. The induced oxidative stress stimulates a local innate response via activation of the toll-like receptors and the NF-κB. Those kinds of reactions are also activated by viral infections. Virus-induced oxidative stress plays an important role in the regulation of the host immune system and the specific oxidant-sensitive pathway is one of the effective strategies against viral infections. Therefore, nose/mouth/throat washing with hydrogen peroxide may enhance those local innate responses to viral infections. The investigators hypothesised that a treatment with a mouth wash and a nasal spray containing a diluted solution of hydrogen peroxide may accelerate the negativisation rate of a positive PCR swab test for SARS-CoV-2 (COVID-19).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •recent positive SARS-CoV-2 PCER swab test
排除标准
- •severe Covid19 disease
结局指标
主要结局
The negativisation rate of a positive SARS-CoV-2 (COVID-19) PCR nose swab test
时间窗: 4 days
A repeated SARS-CoV-2 PCR nose swab test after a previous positive SARS-CoV-2 PCR nose swab test
次要结局
未报告次要终点
研究者
Antonio Lazzarino
Director
EPISTATA
