EUCTR2020-002733-15-FR
进行中（未招募）
1 期
A RANDOMIZED, DOUBLE BLIND, MULTICENTER, PLACEBO CONTROLLED, PARALLEL GROUP, EXPLORATORY EFFICACY AND SAFETY STUDY OF GLENZOCIMAB IN SARS-Cov-2-RELATED ACUTE RESPIRATORY DISTRESS SYNDROME - GARDEN: Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdome
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ACTICOR BIOTECH
- 入组人数
- 40
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female hospitalized patients \= 18 years (i.e., at least 18 years old at the time of randomization) and \< 80 years, having given their written consent.
- •2\. Having a positive RT\-PCR test for COVID\-19
- •3\. Presenting with symptoms of COVID\-19, including:
- •Shortness of breath or difficulty breathing
- •OR at least 2 of the following
- •Fever, defined as any body temperature 38ÅãC
- •Repeated shaking with chills
- •Muscle pain
- •Sore throat
- •New loss of taste or smell
排除标准
- •1\. Patients requiring immediate admission to the ICU,
- •2\. Patients requiring invasive mechanical ventilation,
- •3\. Obvious disseminated intravascular coagulation (DIC), with
- •low platelet count (\<100,000/mL), altered fibrinogen (elevated
- •\>2g/L or low \<1g/L), prolonged PT \> 12sec and/or aPTT \>
- •60sec, presence of fibrin degradation products in the plasma,
- •with or without clinically visible hemorrhagic signs ,
- •4\. ARDS of another origin,
- •5\. Concomitant pulmonary infection (pneumoniae) with another
- •agent, notably bacterial or fungal,
结局指标
主要结局
未指定
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