CTRI/2023/01/048838尚未招募3 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 - ASUCOV
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 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
入选标准
- •The patient or his/her legal authorized representative (in case the patient is unable to give own consent due to his/her medical condition) has given informed consent to participate in the trial and to adhere to the procedures stated in the protocol.
- •The patient is a male or female adult aged >=18 years at the time of giving informed consent.
- •The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 polymerase chain reaction (PCR) test.
- •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.
- •The patient is willing to follow effective measures of contraception during the trial.
排除标准
- •The patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.).
- •The patient is pregnant or breastfeeding.
- •The patient is anticipated to be discharged from hospital within 48 hours.
- •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).
- •The patient requires invasive mechanical ventilation.
- •The patient is known to have active tuberculosis.
- •The patient is known to have hereditary fructose intolerance.
- •The patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).
- •The patient was or is currently participating in any investigational clinical study, other than observational, within 30 days prior to enrollment.
研究者
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