EUCTR2020-001367-88-DK进行中（未招募）1 期
Efficacy and safety of novel treatment options for adults with COVID-19 pneumonia. A double-blinded, randomized, multi-stage, 6-armed placebo-controlled trial in the framework of an adaptive trial platform - CCAP-RCT
Department of Infectious diseases0 个研究点目标入组 6 人开始时间: 2020年4月1日最近更新:
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
- 6
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
- •?=18 years of age
- •?Confirmed COVID-19 infection per WHO criteria / presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
- •?Evidence of pneumonia given by at least one of the following:
- •?SpO2 =93% on ambient air or PaO2/FiO2 <300 mmHg/40 kPa
- •?Radiographic findings compatible with COVID-19 pneumonia
- •?Onset of first experienced symptom, defined as one respiratory symptom or fever, no more than 10 days before admission
- •?For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
- •?Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 750
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 750
排除标准
- •?In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
- •?History of allergic reaction to study drug (as judged by the site investigator)
- •?Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)
- •?Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination or patients family planning within three months after receiving study agent
- •?Estimated glomerular filtration (eGFR) <30 ml/min
- •?Severe liver dysfunction (Child Pugh score C)
- •?Known history of the following medical conditions:
- •?Active or latent tuberculosis (TB) or history of incompletely treated TB
- •?Chronic hepatitis B or C infection
- •?Retinopathy or maculopathy
- •?Neurogenic hearing impairment
- •?Presence of any of the following abnormal laboratory values at screening:
- •?Absolute neutrophil count (ANC) less than 1000 mm3 (= 1,0 x 10? /L)
- •?Alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN)
- •?Platelet count <50,000 per mm3 (= 50 x 10? /L)
- •?Immunosuppression, defined as following:
- •?Treatment with immunosuppressive agents, chemotherapy or immunomodulatory drugs within 30 days prior to inclusion
- •?Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisolone 20 mg or equivalent per day for 4 weeks
- •?Ongoing chemotherapy
- •?Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
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