A Multicenter, Randomised, Controlled, Open Label Trial on the Efficacy and Safety of Asunercept for Patients With Severe COVID-19 Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Apogenix AG
- 入组人数
- 438
- 试验地点
- 13
- 主要终点
- Time to sustained improvement of one category (i.e. two consecutive days) from randomisation
研究概览
简要总结
This is an open-label, randomized, phase II study with the main objective to investigate the effectiveness and safety of an investigational drug (APG101; International Nonproprietary Name: asunercept) in patients with severe COVID-19 disease. The study aims to decrease overall and SARS-CoV-2 associated pneumonia mortality in patients with COVID-19 as well as to decrease the percentage of patients admitted to Intensive Care Unit (ICU), decrease the need to supply oxygen to patients, reduce the number of days patients are hospitalized in ICU and/or on the ward, decrease the number of days required to obtain a negative result in the PCR (Polymerase Chain Reaction, a laboratory technique that allows the amplification of small fragments of DNA to detect the presence of the virus) test for COVID-19 and decrease the levels of markers that indicate pneumonia.
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
- •Laboratory confirmed infection with SARS-CoV-2 OR typical radiological signs of SARS-CoV-2 infection
- •Hospitalisation due to COVID-19
- •Informed Consent obtained, the patient understands and agrees to comply with the planned study procedures. If a potential patient is unconscious, the Patient Information Sheet with the Informed Consent Form can be signed by the legal representative, if he/she accompanies the patient. It can be signed by a Concilium consisting of doctors (2), investigator and an independent witness in case the legal representative is not available.
- •≥18 years of age
- •Willingness to perform effective measures of contraception during the study.
- •Signs of respiratory deterioration such as oxygen saturation ≤94% when breathing ambient air or >3% drop in oxygen saturation in case of chronic obstructive lung disease OR need for oxygen supplementation to achieve satisfactory blood oxygen saturation (sPO2>90% at room air) as well as the need for non-invasive ventilation, high-flow oxygen devices or mechanical ventilation or radiological or clinical signs of pneumonia.
排除标准
- •Moribund, or estimated life expectancy <1 month (e.g., terminal cancer, etc.)
- •Patient does not qualify for intensive care, based on local triage criteria
- •Pregnancy or breast feeding
- •Severe liver dysfunction (e.g. ALT/AST > 5 times upper limit of normal)
- •Anticipated discharge from hospital within 48 hours
- •Other potent anti-inflammatory treatment, e.g. TNF- blocking therapies
- •Mechanical ventilation for >48 hours
- •Known active HIV or viral hepatitis infection
- •Known active tuberculosis
- •Known hereditary fructose intolerance
结局指标
主要结局
Time to sustained improvement of one category (i.e. two consecutive days) from randomisation
时间窗: Day 1-29
The primary endpoint is time to clinical improvement which is defined as time from randomisation to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomisation measured on a nine-category ordinal scale (proposed by WHO).
次要结局
- Efficacy according to the National Early Warning Score (NEWS)(Day 1-29)
- Oxygenation(Day 1-29)
- Ventilation(Day 1-29)
- Hospitalisation - Length(Day 1-29)
- Hospitalisation - Proportion on ICU(Day 1-29)
- Mortality(Up to 90 days)