Use of a Medical Device, Viruxal Oral and Nasal Spray, for Treating the Symptoms of COVID-19 Via Application to the Naso- and Oropharyngeal Mucosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kerecis Ltd.
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Number of days until complete resolution of symptoms per group
研究概览
简要总结
Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf (the "Device"). A double blind clinical trial will be conducted to evaluate the Device against placebo in COVID-19 positive, symptomatic patients in Iceland. Immediate access to COVID-19 patients is available through a well-organized COVID-19 outpatient follow-up clinic. Up to 128 patients with mild to moderate symptoms of COVID-19 will be recruited (so called "higher end of the low risk group"). These patients will be positive for COVID-19, be symptomatic with upper respiratory symptoms, but without involvement of the entire respiratory system. The patients will be randomized to receive treatment with the Study Device or to receive placebo. 64 patients will be randomized into the Study Device group and 64 patients into the Control group. Patients will administer Study Device or Control for 14 days and will have their symptoms recorded until no further symptoms are reported, up to a maximum of 28 days follow-up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Positive for SARS-CoV-2 infection
- •Has symptoms of upper respiratory infection
- •Willing to participate in the clinical trial and gives consent
- •Is not pregnant, nor actively trying to conceive a child.
排除标准
- •Under 18 years of age
- •Negative for SARS-CoV-2 infection
- •Severe symptoms of infection
- •Symptoms involving the entire respiratory system, including Pneumonia
- •Requires hospitalisation prior to study start
- •Asymptomatic
- •Pregnant or actively trying to conceive a child
- •Other comorbidities that would prevent administration of the device
- •Requirement to take regular medications administered by inhalation, or via the naso- and oropharyngeal route
- •Patients with known allergies to Neem or Hypericum oil
- •Patients with asthma
结局指标
主要结局
Number of days until complete resolution of symptoms per group
时间窗: 28 days
The number of days until participants report no symptoms, which they attribute to COVID-19, will be compared between groups. Symptoms include: Fever (38.0°C or higher), chills, dry cough, cough with rise, shortness of breath (rest), shortness of breath (Exercise), dyspnoea, sore throat, runny nose, headache, myalgia/bone pain, anorexia, nausea, vomiting, loss of smell, osteoporosis, abdominal pain, diarrhea, weakness.
Number of hospital admissions per group
时间窗: 28 days
The number of participants admitted to hospital due to deterioration of their condition due to COVID-19 will be compared between groups.
次要结局
- Number of days until a reduction in symptoms per group(28 days)
- Number of adverse events per group(28 days)