An Open-label, Prospective, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of ENKORTEN® as an Immunomodulatory Therapy, Within the Usual Therapeutically Established Protocol, for the Treatment of Patients With Moderate to Severe COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Time to onset of change in the patient's clinical condition
研究概览
简要总结
An Open-label, prospective, randomized, comparative, multiple doses applied in addition to the standard of care treatment of patients with moderate to severe COVID-19 infection
详细描述
The justification for the use of immunomodulatory therapy is based on the evidence that drugs that are inhibitors of interleukin IL6 may prevent the more severe lung tissue damage caused by cytokine release in patients with more severe COVID19. Several studies have suggested a "cytokine storm" caused by the release of IL-6, IL-1, IL-12 and IL-18 with tumor necrosis factor TNF alpha and other inflammatory mediators. Increased inflammatory response of lung tissue may result in increased gas exchange at the alveolar-capillary level making oxygenation difficult in patients with more severe forms of the disease and the need for mechanical ventilation. In this regard, it is hypothesized that the use of immunomodulatory therapy should have an effect in reducing the lethal outcome, the need for oxygen therapy, and mechanical ventilation.
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
- None
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
- •Patients with laboratory-confirmed (PCR) COVID-19 infection
- •Patients with moderate to severe COVID-19 infection
- •Hospitalized patients on clinical centers and cantonal hospitals
- •Patients with radiology-confirmed pneumonia within the clinical condition of COVID-19 infection including pulmonary opacity
- •Patients with a clinical indication for pneumonia: increased body temperature (defined as a value above ≥ 36.6⁰C axillary route, ≥ 37.2°C oral route or ≥ 37.8 °C rectal route), and/or dyspnea, and/or cough, and/or SpO2 <96%
- •Patients aged above 18, both genders
- •Patients able and willing to understand the study, adhere to all study procedures and sign a written Informed Consent Form (ICF) prior to entering the study or with the assistance of the witness
排除标准
- •Patients not COVID-19 positive
- •Patients with mild COVID-19 infection
- •Patients who are study subjects in another clinical study for another investigational agent for COVID-19
- •Patients with malignant hypertension
- •Patients with malignant disease and who are treated for malignant diseases in the last 5 years
- •Patients with severe liver and kidney insufficiency
- •Patients who are receiving therapy with an immunomodulatory or immunosuppressive agent
- •Patients aged below 18, female patients who are pregnant or breastfeeding
- •Known allergy to study drug or any component thereof
- •Use of haloperidol, dopamine antagonists, or nonsteroidal anti-inflammatory drugs, except paracetamol.
研究组 & 干预措施
ENKORTEN
干预措施: metenkefalin + tridecactide (Drug)
The standard of care treatment
The usual therapeutically established protocol for the treatment of patients with moderate to severe COVID-19 infection
干预措施: The standard of care (Drug)
结局指标
主要结局
Time to onset of change in the patient's clinical condition
时间窗: 21 day
The time of onset of improvement in the patient's clinical condition will be measured following the clinical objective and subjective signs and radiological indicators.
Safety and tolerability evaluation - treatment-related adverse events will be assessed by CTCAE
时间窗: 21 day
At every examination/evaluation, all AEs, whether noticed by investigators and their associates in the trial, or spontaneously reported by the subjects, or given as answer to direct question, must be evaluated by the investigator and reported on case report forms for AE. AE will be recorded in the e-CRF. Three-degree scale will be used for assessment of AE's severity: mild, moderate, severe.
次要结局
- Length of in-hospital stay(21 day)
- Survival rate(21 day)
- Intubation rate(21 day)
- Proinflammatory markers levels(21 day)