NL-OMON53826尚未招募2 期
Potential of FX06 to prevent disease progression in hospitalised nonintubated COVID-19 patients (Ixion) - IXIO
F4Pharma GmbH i.G.0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. SARS-CoV-2 infection confirmed by PCR test
- •2. Hospitalised patients
- •3. WHO score 4-6
- •4. Oxygen saturation <= 92% under room air
- •5. Breathing frequency per minute >= 20
- •6. Patients >= 18 years
- •7. Written informed consent obtained prior to the initiation of any
- •protocol-required procedures by the patient
- •8. Willingness to comply to study procedures and study protocol
- •9. Patients able to understand the requirements of the study and give written
- •informed consent
排除标准
- •1. Significant underlying known co-morbidities or conditions, defined as:
- •o Other severe advanced or chronic lung diseases (e.g., COPD Gold >= III, severe
- •o End-stage chronic kidney disease (stage 5)
- •o End-stage chronic heart failure (NYHA >= III)
- •o Baseline neurologic disease which would preclude rehabilitation potential
- •o Disseminated and/or metastasised malignancy
- •o Severe deconditioning with a life expectancy of less than 6 months according
- •to the treating physician
- •o Immunocompromised patients
- •- recipient of a solid organ transplant
- •- regular intake of anti-inflammatory therapy due to concomitant auto- immune
- •diseases (e.g., biologics)
- •- primary immune deficiency
- •2. Evidence of other significant uncontrolled concomitant diseases or serious
- •and/or uncontrolled diseases with a bad prognosis that are likely to interfere
- •with the evaluation of the patient's safety and with the study outcome as
- •judged by the treating physician
- •3. Women pregnant or breastfeeding
- •4. Males or females of reproductive potential not willing to use effective
- •contraception for the duration of the study period (defined as PEARL index <1
- •e.g., contraceptive pill, IUD or true sexual abstinence, bilateral tubal
- •occlusion or male partner with vasectomy; also see chapter 19.2 for guidance)
- •5. Current participation in another interventional clinical trial with IMP or
- •participation within the last 30 days
研究者
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