jRCT2031220353进行中（未招募）不适用
A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 (SCORPIO-HR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •For all participants:
- •Participants who are >= 18 years at the time of signing the informed consent.
- •Participants who were diagnosed as SARS-CoV-2 positive within 72 hours before randomization.
- •Participants with time from COVID-19 onset to randomization of =< 72 hours.
- •(COVID-19 symptoms: Cough, Shortness of breath or difficulty breathing, Feeling feverish, Chills, Fatigue, Body pain or muscle pain or aches, Diarrhea, Nausea, Vomiting, Headache, Sore throat, Nasal obstruction or congestion, Nasal discharge, Loss of taste or smell)
- •Participants who have one or more of the above signs/symptoms(except loss of taste or smell) present within 24h prior to randomization.
- •Participants with oxygenation saturation of >= 92% on room air adjusted for altitude and obtained at rest by study staff within 24h prior to randomization.
- •For high-risk participants:
- •Participants who are >= 65 years at the time of signing the informed consent.
- •Participants who are >= 18 years at the time of signing the informed consent with 1 of the following: Obesity (BMI>=30), Diabetes mellitus, Hypertension, Cardiovascular disease, Chronic lung disease (e.g., COPD, modrate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Chronic kideney disease (except for CrCl<30mL/min), Down syndrome, Sickle cell disease, Immunocompromising conditions or immunosuppressive treatments.
- •For Standard-risk participants:
- •Participants at low risk for progression to severe COVID-19 are defined as <65 years of age and with none of the risk factors
排除标准
- •Participants who have history of hospitalization for the current SARS-CoV-2 infection.
- •Participants with current need for hospitalization or immediate medical attention in the opinion of the
- •investigator.
- •Participants with current use of any medications prohibited with the study intervention, or use of any medication intended to treat symptomatic SARS-CoV-2 infection before randomization.
- •Participants with any comorbidity requiring surgery within 7 days prior to randomization or that is
- •considered life threatening in the opinion of the investigator within 28 days prior to randomization.
- •Known current renal impairment defined as CrCl <30 mL/min by Cockcroft-Gault or requiring dialysis.
- •Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
- •Participants who have used any of the following drugs within 14 days prior to randomization (strong CYP 3A inducer, products containing St. John's wort)
结局指标
主要结局
-
- The time to sustained symptom resolution
次要结局
未报告次要终点
研究者
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