A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear 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
- 1
- 主要终点
- Hasten baseline reactive to non-reactive on COVID 19 RT PCR
研究概览
简要总结
This study aims to find out the efficacy of Xlear nasal spray as an adjunct medication against COVID-19. This encompasses reduction in the number of days to negativization via nasal swab PCR from the average 14 days and early improvement of symptoms.
详细描述
Patients will be informed about the study including potential risk and benefits. Once written informed consent are obtained, patients will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, eligible patients will be placed in a randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nostrils, 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 Reverse Transcriptase PCR (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
- •Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
- •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 2 liters 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 grapefruit seed extract (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
干预措施: Xlear Nasal Spray (Drug)
Placebo
Saline nasal spray, 2 puffs per nostrils, every 6 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Hasten baseline reactive to non-reactive on COVID 19 RT PCR
时间窗: Baseline and 7 days
The COVID 19 RT PCR is the gold standard in the detection of COVID 19 in patients. With the average time to negativization being 14 days. This study aims to reduce the reactivity to 7 days.
次要结局
- Change of symptoms(Baseline and 7 days)