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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Apogenix AG
- 入组人数
- 636
- 试验地点
- 10
- 主要终点
- scale or discharge from hospital followed by being alive and at home for
研究概览
简要总结
Trial APG101_CD_018 is aprospective, multicenter, randomized, double-blind, placebo-controlled PhaseIII trial to evaluate the efficacy of Asunercept for the treatment ofhospitalized patients with moderate to severe COVID-19 corresponding to score 5or 6 on the WHO 10-point clinical progression scale (Grade 0-10). Patients willbe randomized in a 1:1 ration into two study arms: Asunercept will be given ata dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1dose each on d1, d8, d15, and d22) in addition to the treatment recommended byinternational, national, or local treatment guidelines (SoC) and will becompared with the control arm (i.e., SoC + placebo). Approximately 640 patientsare planned to be enrolled in nine countries and a total of up to 50 studysites; 10 sites will participate in India. The primary endpoint is time tosustained recovery, defined as sustained improvement (i.e., without decrease) of≥2 points on the WHO 10-point clinical progression scale or discharge fromhospital followed by being alive and at home for 14 consecutive days prior today (d) 56, whichever occurs first. The key secondary endpoint is all-causemortality or progression to invasive mechanical ventilation (IMV) by day 28after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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-
- •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-
- •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.
结局指标
主要结局
scale or discharge from hospital followed by being alive and at home for
时间窗: 14 consecutive days prior to day (d) 56, whichever occurs first
Time to sustained recovery, defined as sustained improvement (i.e.,
时间窗: 14 consecutive days prior to day (d) 56, whichever occurs first
without decrease) of ≥2 points on the WHO 10-point clinical progression
时间窗: 14 consecutive days prior to day (d) 56, whichever occurs first
14 consecutive days prior to day (d) 56, whichever occurs first
时间窗: 14 consecutive days prior to day (d) 56, whichever occurs first
次要结局
- All-cause mortality or progression to invasive mechanical ventilation((IMV) by d28)