EUCTR2020-005979-12-BG进行中（未招募）1 期
An international, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of 150 mg XAV-19 infusion, in patients with moderate COVID-19: the EUROXAV study - EUROXAV Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- XENOTHERA
- 入组人数
- 870
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
- •I1) Male or female patient aged 18 years or over, weighing >40 Kg and <120 Kg, at the time of signing the informed consent,
- •I2) Patient presenting in a specialized or an emergency unit
- •I3) Patient presenting signs of respiratory disease due to covid-19, evidenced by clinical assessment or imaging
- •COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea
- •I4) Patient with SpO2 > 90% (at ambient air)
- •Patient requiring or not oxygen-therapy (score =4 or 3 on WHO clinical progression 7 point ordinal scale respectively)
- •I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening
- •I6) Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening and use a highly effective birth control until 90 days after the administration of study drug
- •I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug
- •I8) Patient capable of giving signed informed consent
- •I9) Patient requiring or not oxygen-therapy (score 2, 3 or 4 on WHO clinical progression 7point ordinal scale respectively)
- •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 348
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 522
排除标准
- •E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit
- •E2) Patient with multiorgan failure
- •E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization
- •E4) Patient participating in another clinical trial with an investigative agent
- •E5) Pregnancy or breastfeeding
- •E6) Patient with critical respiratory illness meeting one of the following criteria: high flow oxygenation, NIV, invasive mechanical ventilation or ECMO
- •E7) Patient requiring oxygenation at a flow rate > 6L/min
- •E8) Patients presenting any of clinical signs indicative of severe systemic illness, such as respiratory rate =30 per minute, heart rate =125 per minute, or PaO2/FiO2 <300
研究者
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