EUCTR2020-001805-21-GB进行中（未招募）1 期
Prospective, Randomized, Parallel-Group, Open-Label Study to Evaluate the Efficacy and Safety of IMU-838, in Combination with Oseltamivir, in Adults with Coronavirus Disease COVID-19 - IONIC study -IMU838 and Oseltamivir in treatment of Novel Coronavirus
niversity Hospital Coventry & Warwickshire0 个研究点目标入组 120 人开始时间: 2020年5月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or non-pregnant female patients at least 18 years old
- •2.Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection
- •?Confirmed cases: prospective participants who tests positive to a validated specific SARS-CoV-2 nucleic acid test or has the virus identified by electron microscopy or viral culture, as per local trust policy = 5 days before randomization.
- •?Probable/Suspected case: prospective participitants who have been in contact with a confirmed case of COVID-19, AND has mild to severe Covid-19 clinical symptoms AND radiographic evidence* of pulmonary infiltrates consistent with Covid-19 disease
- •3.Moderate to severe COVID-19 requiring hospitalisation defined as:
- •a)Clinical status category 3-5 (inclusive) on the 7-point clinical status category scale as proposed by the World Health Organisation (WHO) master protocol:
- •I.Category 3: hospitalized, no oxygen therapy
- •II.Category 4: hospitalized, oxygen by mask or nasal prongs
- •III.Category 5: hospitalized, non-invasive ventilation or high-flow oxygen
- •*where routinely available, no tests will be requested for research purpose
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.General exclusion criteria
- •Allergic or hypersensitivity to the IMU-838, Oseltamivir, or any of the ingredients
- •Pregnant or breastfeeding or with intention to become pregnant during the study
- •Participants who cannot take trial medication orally
- •2.Concomitant Medication or Medical History:
- •?If the attending clinician believes that there is a specific contra-indication to the IONIC intervention (see Appendix 3; section 9.1.2)
- •?Patient has a medical or concomitant disease history preventing him to participate ( for further information please see; Appendix 3 in protocol)
- •3.COVID-19 related exclusion criteria
- •Participation in any other interventional clinical trial for an experimental treatment for COVID-19
研究者
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