EUCTR2021-006005-30-DE进行中（未招募）1 期
A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients with Moderate to Severe COVID-19 Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Apogenix AG
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
- 性别
- All
入选标准
- •1. The patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol
- •2. The patient is a male or female adult aged =18 years at the time of giving informed consent
- •3. The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test
- •4. The patient has clinical symptoms indicative of moderate or severe illness (corresponding to score 5 [oxygen by mask or nasal prongs] or 6 [oxygen by non-invasive ventilation or high flow] on the WHO 10-point clinical progression scale) with COVID-19 prior to trial treatment on d1: Radiologically confirmed pneumonia due to COVID-19 and/ or clinical signs suggestive of moderate/severe illness with COVID-19
- •5. The patient agrees to not participate in another clinical trial from screening until d56
- •6. The patient is willing to follow effective measures of contraception during the trial
- •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 512
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 128
排除标准
- •1. The patient is moribund or has an estimated life expectancy <1 month
- •2. The patient is pregnant or breastfeeding
- •3. The patient is anticipated to be discharged from hospital within 48 hrs
- •4. The patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19. In addition, SoC comprises medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)
- •5. The patient requires invasive mechanical ventilation
- •6. The patient is known to have active tuberculosis
- •7. The patient is known to have hereditary fructose intolerance
- •8. The patient is known to have co-infection with Influenza viruses or other viral respiratory infections
研究者
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