Use of Inhaled High-molecular Weight Hyaluronan in Patients With Severe COVID19: Feasibility and Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cumulative time on oxygen
研究概览
简要总结
To determine whether inhaled Yabro protects against progression of COVID19-induced respiratory failure preventing the passage to non-invasive ventilation (NIV) and promotes recovery from COVID19 lung disease in hospitalized patients.
详细描述
All patients will be treated with state of the art COVID19 treatment as per the treating clinician (Remdesivir, systemic corticosteroids, monoclonal antibodies, convalescent plasma, biologic cytokine inhibitors and other interventions as per the latest guidelines). Patients randomized to the active intervention group will also receive HMW-HA (Yabro®, 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer, while patients randomized in the control group will receive a matching placebo two times daily.
Due to increased risk for SARS-CoV-2 transmission via the usual mask nebulization procedure, patients will receive the nebulized treatment via high-flow oxygen tubing as described in the literature 36-38. Patients will be treated until there is a qualitative change in oxygen requirement, i.e. either progression to assisted ventilation (non-invasive or invasive), or weaning from oxygen supplementation. Because COVID19 may result in long-term O2 dependency, the study and treatment period will be limited to a maximum of 10 days.
Moreover, a blood sample (20 ml) will be taken at baseline and after 10 days of treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of COVID19 by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) and no alternative explanation for current clinical condition.
- •Respiratory failure requiring oxygen therapy
- •Has symptoms consistent with COVID-19, and is in non-fibroproliferative stage of disease, as determined by investigator.
排除标准
- •Respiratory arrest or the need for immediate intubation;
- •Upper airway obstruction;
- •Facial trauma;
- •Inability to cooperate (e.g. agitation or dementia)
- •Inability to give informed consent
- •Participation in another study for COVID19 treatments
- •Deterioration due to other reasons than progressive COVID19 pneumonia per clinical judgment, e.g. pulmonary thromboembolism, heart failure, renal failure etc.
- •Palliative care or expectation that patient will not survive > 72 hours post randomization per clinical judgment of the investigator.
研究组 & 干预措施
HMW-HA
HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt)
干预措施: HMW-HA (Drug)
placebo
5 ml of saline via nebulizer b.i.d.
干预措施: HMW-HA (Drug)
结局指标
主要结局
Cumulative time on oxygen
时间窗: 10 days
cumulative duration of oxygen treatment
次要结局
- Rate of change of respiratory rate;(10 days)
- Change in PaO2 /FiO2 ratio during treatment(10 days)
- Need for advanced airway intervention or death due to COVID19;(10 days)
- Time to discharge from hospital(10 days)