A Randomized Placebo Control Trial to Evaluate the Efficacy of Xylitol Nasal Spray vs. Placebo for Acute COVID-19 Infection
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days
研究概览
简要总结
The purpose of this study is to assess the efficacy of Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray as an adjunct treatment of COVID-19.
详细描述
After being informed about the study and potential risk, all patients giving written informed consent will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, patients who meet the eligibility requirements will be randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nosetrils, every 3-4 hours a day) or placebo. Patient will be followed for 1 week. Inflammatory markers will be obtained on Day 4 and repeat COVID-19 RT PCR on Day 7. Follow up will be done on Day 14 for all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Masking to care providers
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
- •Adults of ages 18 to 90 years of both sexes
- •With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
- •Signed informed consent
- •1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
- •2- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air SpO2 <92% and >88% or <88% corrected to >92% with 2lt of oxygen)
排除标准
- •Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
- •Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
- •Under 18 years of age
- •Women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test.
- •Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
- •Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liter non-concentrated oxygen) plus severe shortness of breath
- •History of immunodeficiency or are currently receiving immunosuppressive therapy.
- •Have had a planned surgical procedure within the past 12 weeks.
- •Already part of this trial, recruited at a different hospital.
- •Patient unable to perform oro-nasopharyngeal decolonization
- •Patients with acute exacerbation of severe comorbidities like heart disorders Chronic Obstructive Pulmonary Disease (COPD), Heart Failure New York Heart Association (NYHA) Class 3 and 4 and/or diseases with severe oxygenation problems
- •Patients on Remdesivir and/or other clinical trials.
研究组 & 干预措施
Treatment
Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours
干预措施: Nasal Spray (Drug)
Placebo
Saline nasal spray, 2 puffs per nosetrils, every 6 hours
干预措施: Nasal Spray (Drug)
结局指标
主要结局
Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days
时间窗: Baseline and 7 days
The COVID 19 RT PCR is the gold standard in detecting presence of COVID-19 in patients. The average time from reactivity to non-reactivity is 14 days,
次要结局
- Change of time to clinical recovery from baseline within 7 days(Baseline and 7 days)