NCT05616728已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of EDP-235 in Non-hospitalized Adults With Mild or Moderate COVID-19
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 23
- 主要终点
- Number of Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
Study of EDP-235 in Non-hospitalized Adults with Mild or Moderate COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomization
- •COVID-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening
排除标准
- •Prior SARS-CoV-2 infection <90 days before enrollment and/or received any COVID-19 vaccine dose <90 days before enrollment
- •Has one or more conditions associated with high risk for severe COVID-19
- •History of hospitalization for the medical treatment of COVID-19
- •Currently hospitalized or anticipated need for hospitalization in the clinical opinion of the investigator
- •Known medical history of active liver disease
- •Receiving dialysis or have known moderate to severe renal impairment
- •Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug
- •Any comorbidity requiring hospitalization and/or surgery within 7 days before study entry, or that is considered life threatening within 30 days before study entry
- •Known HIV infection with a HIV viral load greater than 400 copies/mL or medication for HIV treatment that is prohibited in this study based on medical history within 6 months before the screening visit
- •History of hypersensitivity or other contraindication to any of the components of the study drug
- •Has received or is expected to receive pre-exposure prophylactic SARS-CoV-2 mAb
- •Has received or is expected to receive convalescent COVID-19 plasma
- •Oxygen saturation of ≤93% on room air obtained at rest within 24 hours before randomization
- •Participating in another interventional clinical study with an investigational agent or device, including those for COVID-19, within 30 days or five half-lives of the agent, whichever is longer, before signing the ICF
- •Females who are pregnant or breastfeeding
研究组 & 干预措施
EDP-235 200mg
Experimental
Once a day orally for 5 days
干预措施: EDP-235 (Drug)
EDP-235 400mg
Experimental
Once a day orally for 5 days
干预措施: EDP-235 (Drug)
Placebo
Placebo Comparator
Once a day orally for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Adverse Events as a Measure of Safety and Tolerability
时间窗: Day 1 through Day 33
次要结局
- Change From Baseline in SARS-CoV-2 RNA Viral Load(Day 3, Day 5, Day 9 and Day 14)
- Change From Baseline in Infectious SARS- CoV-2 Viral Load(Day 3, Day 5, Day 9 and Day 14)
- Proportion of Participants With Medically Attended Visits for COVID-19(Day 1 through Day 33)
- Proportion of Participants With COVID-19 Signs/Symptom Improvement(Day 1 through Day 33)
- Proportion of Participants Who Require Hospitalization and Mechanical Ventilation(Day 1 through Day 33)
- Proportion of Participants All-cause Mortality(Day 1 through Day 33)
- Change From Baseline in COVID-19 Signs/Symptom(Day 1 through Day 33)
- Proportion of Participants Requiring Hospitalization for COVID-19(Day 1 through Day 33)
- Mean Plasma PK Concentrations of EDP-235(Day 1 through Day 5)
研究者
研究点 (23)
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