NCT07746544招募中3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19
Shionogi2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年8月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
研究概览
简要总结
The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 12 to < 18 years of age (where permitted by local regulation) with a body weight ≥ 40 kilograms (kg), or ≥ 18 and < 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF).
- •Must have ≥ 1 of the protocol-defined COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization.
- •Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by any SARS-CoV-2 test, collected ≤ 48 hours prior to randomization.
- •Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs.
- •Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study.
排除标准
- •Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
- •Documented respiratory infection (for example, influenza, respiratory syncytial virus infection) other than COVID 19 within 14 days prior to the screening visit.
- •Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
- •Suspected or confirmed COVID-19 outside of the current episode within 3 months of randomization.
- •Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.
- •Ongoing long COVID or postacute sequelae of COVID (PASC) diagnosis.
- •Current severely immunocompromised conditions.
- •Received or expected to receive any other COVID-19-specific therapies.
- •Have previously received secutrelvir.
- •Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit.
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Secutrelvir
Experimental
Participants will receive secutrelvir administered orally.
干预措施: Secutrelvir (Drug)
Placebo
Placebo Comparator
Participants will receive placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21
时间窗: Baseline through Day 21
Symptoms will be assessed by the investigator via a participant daily electronic diary.
次要结局
- Change From Baseline in SARS-CoV-2 Viral RNA Level(Baseline through Day 28)
- Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28(Baseline through Day 28)
- Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21(Baseline through Day 21)
- Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28(Baseline through Day 28)
- Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21(Baseline through Day 21)
- Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21(Baseline through Day 21)
- Area Under The Curve (AUC) of Change From Baseline in Protocol-defined 14 COVID 19 Symptoms Total Score at Day 8(Baseline, Day 8)
- Time to First Resolution of Fever Based on Body Temperature(Baseline through Day 28)
- Time to Sustained Resolution of Fever Based on Body Temperature(Baseline through Day 28)
- Percentage of Participants With All-cause Hospitalization(Baseline through Day 21)
- Percentage of Participants With All-cause Death(Baseline through Day 21)
- Plasma Concentration of Secutrelvir and Its Metabolites(Days 4 and 8)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Baseline through Day 28)
研究者
研究点 (2)
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