Efficacy and Safety Evaluation of Inhaleen Inhalation in Hospitalized COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Clinical status of subjects as expressed on the WHO-8-Category ordinal scale:
研究概览
简要总结
The current study will investigate the tolerability and efficacy of inhaled Carragelose® versus saline in hospitalized COVID-19 patients. As SARS-CoV-2 replicates readily in the lung, it is planed to apply Carragelose® in an inhalative form. Hospitalized COVID-19 patients with respiratory symptoms will inhale Inhaleen for 5 days.
详细描述
The tolerability and efficacy of inhaled Carragelose® will be investigated in a randomized, double blind, placebo-controlled trial in hospitalized COVID-19 patients.
Patients will inhale Inhaleen or Placebo 3 times a day for 7 minutes for 5 days.
The primary objective of the trial is to demonstrate that Inhaleen inhalation improves the clinical status of hospitalized COVID-19 patients on day 8 compared to placebo inhalation.
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, Investigator)
盲法说明
double blinded
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
- •Written informed consent obtained before any trial related procedures are performed
- •Age ≥ 18 years
- •Hospitalized patients with PCR confirmed SARS-CoV-2 infection and symptom onset ≤ 10 days before randomization
- •Patients with respiratory COVID-19 symptoms
- •Randomization ≤ 48h from admission
- •Peripheral capillary oxygen saturation (SpO2) ≥ 90% on room air or supplemental oxygen at screening
- •Patient agrees to refrain from taking other carragelose products (e.g. throat spray, lozenges)
排除标准
- •No informed consent
- •Persistent hypoxemia with SpO2 < 90% despite supplemental oxygen of > 6LO2/min at screening.
- •Patients with predominantly extrapulmonary COVID-19 symptoms (e.g. gastrointestinal, neurological, etc.)
- •Subjects who demonstrate respiratory and/or cardiac instability that is considered by the investigator as a reason for exclusion. Additionally, any other clinically significant disease that could interfere with participation in the study, with the intervention being studied, or with the evaluation of symptoms. Specific exclusions are asthma, immune deficiency, autoimmune disease, clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or any disease that is considered by the investigator as a reason for exclusion.
- •Known hypersensitivity or allergy to any component of the test product
- •The subject is related to any study personnel or has any other close ties or conflicts of interest with the study sponsor.
- •The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
- •Current medication other than oral contraception,that is considered by the investigator as a reason for exclusion.
- •Pregnant/lactating women at the time of recruitment will be excluded from the study
- •Participation in another antiviral clinical trial
结局指标
主要结局
Clinical status of subjects as expressed on the WHO-8-Category ordinal scale:
时间窗: day 8
1. Not hospitalized and no limitations of activities 2. Not hospitalized, with limitations of activities, home oxygen requirement, or both 3. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infections-control or other nonmedical reasons) 4. Hospitalized not requiring supplemental oxygen but requiring ongoing medical care related to COVID-19) or to other medical conditions) 5. Hospitalized requiring any supplemental oxygen 6. Hospitalized requiring non-invasive ventilation or use of high-flow oxygen devices 7. Hospitalized receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 8. Death
次要结局
- Cycle threshold of SARS-CoV-2 PCR·(until day 15)
- modified 10 point BORG scale(day 1 to day 5)
- supplemental oxygen requirement(until day 15)
- multiplex viral examination(until day 15)