NCT05716425已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,218
- 试验地点
- 2
- 主要终点
- Time from the first dose to sustained recovery from 11 target symptoms of COVID-19.
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of STI-1558 in adult subjects with mild/moderate COVID-19. One thousand and two hundred adult subjects with mild/moderate COVID-19 (including subjects with high risk factors for progression into severe cases) are planned to be enrolled and randomized in a ratio of 1:1 into the test group or the placebo group (600 in the test group and 600 in the placebo group).
详细描述
One thousand and two hundred adult subjects with mild/moderate COVID-19 (including subjects with high risk factors for progression into severe cases) are planned to be enrolled and randomized in a ratio of 1:1 into the test group or the placebo group. Randomization and stratification factors include clinical type (mild vs. moderate) of COVID-19, high risk factors for severe disease (with vs. without), history of SARS-CoV-2 vaccination or infection (yes vs. no). Subjects in the test group will receive STI-1558, and subjects in the placebo group will receive STI-1558 placebo. STI-1558 and STI-1558 placebo will be orally administered under fasting condition twice daily (BID) for 5 days (10 doses in total) at a dose of 600 mg and 0 mg, respectively; the two doses administered will be at a minimum interval of 8 hours (≥8 h). Efficacy and safety will be assessed until D29 after the first dose.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥18 years;
- •Subjects comply with the diagnostic criteria for mild or moderate COVID-19 specified in the Protocol for the Diagnosis and Treatment of Novel Coronavirus Pneumonia (Trial Version 9) released by China's National Health Commission;
- •First presence of positive RT-PCR or rapid antigen assay for SARS-CoV-2 with nasopharyngeal or oropharyngeal swabs within 4 days prior to the first dose (≤4 days from the first dose);
- •First presence of at least 1 of 14 symptoms of COVID-19 within 3 days prior to the first dose (≤3 days/72 hours from the first dose) ;
- •Subjects with at least 2 of 11 target symptoms of COVID-19 within 24 hours prior to the first dose (≤24 hours from the first dose), including at least 1 designated symptom (Stuffy or runny nose, Sore throat or dry throat, Cough, Feeling hot or feverish, Shortness of breath or difficulty breathing), and score of at least 1 designated symptom ≥2 ;
- •Women of childbearing potential (WOCBP) (women of non-childbearing potential defined as women who have undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition, or sexually mature women spontaneously menopausal for ≥ 12 months) must have a negative pregnancy test during the screening period;
- •Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use a highly effective contraceptive method from screening to 30 days after the last dose;
- •Can understand and abide by the procedures and methods of this clinical trial.
排除标准
- •Known allergy to any ingredient of the study drug;
- •Subjects comply with the diagnostic criteria for severe or critical COVID-19 specified in the Protocol for the Diagnosis and Treatment of Novel Coronavirus Pneumonia (Trial Version 9) released by China's National Health Commission prior to the first dose;
- •Subjects urgently require or is expected to require nasal high-flow oxygen therapy or non-invasive positive pressure ventilation, invasive mechanical ventilation or ECMO prior to the first dose;
- •Subjects with abnormal liver function at screening: total bilirubin ≥ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN;
- •Subjects with active or uncontrolled hepatopathy: including cirrhosis, Child-Pugh grade B or C, acute liver failure, etc.;
- •Subjects with concomitant severe renal insufficiency (estimated glomerular filtration rate [eGFR]<45 mL/min, calculated using the serum creatinine based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation, refer to Appendix 6 for the calculation formula) or on continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
- •Subjects with impaired immune system (including subjects who are on systemic or inhaled corticosteroids or other immunosuppressants, or subjects with cancer progression or recurrence, or with human immunodeficiency virus [HIV] infection);
- •Subjects with acute episodes of chronic respiratory diseases (including bronchial asthma, chronic obstructive pulmonary disease, etc.);
- •Subjects with a history of dysphagia or any gastrointestinal disorder that affects drug adsorption;
- •Subjects with suspected or confirmed acute systemic infections other than COVID-19 (e.g., concomitant influenza), which may interfere with the evaluation of responses to the study intervention;
- •Subjects who have underwent major surgery within 14 days prior to the first dose, or have not completely recovered from surgery or plan to undergo surgery during the study period;
- •Subjects with complications that are, in the opinion of the investigator, life-threatening within 30 days prior to the first dose;
- •Subjects have received anti-SARS-CoV-2 chemical drugs such as 3CL protease inhibitors or RNA dependent RNA polymerase (RdRp) inhibitors or angiotensin converting enzyme 2 (ACE-2) and transmembrane protease serine 2 (TMPRSS2) degrading agents within 14 days prior to the first dose;
- •Subjects have received COVID-19 patients' convalescent plasma or COVID-19 human immunoglobulin or interleukin-6 (IL-6) inhibitors or anti-SARS CoV-2 neutralizing antibodies within 30 days or 5 half-lives (whichever is longer) prior to the first dose;
- •Subjects have had any SARS-CoV-2 vaccination within 3 months prior to the first dose;
- •Subjects have received any potent inhibitor or inducer of cytochrome P450 (CYP) 3A4 within 28 days or 5 half-lives (whichever is shorter) prior to the first dose;
- •Subjects who are currently participating in an interventional clinical study of other investigational drugs or devices, including other studies on COVID-19;
- •Subjects have received any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose;
- •Subjects have previously participated in this study or other studies of STI-1558;
- •Pregnant or lactating women;
- •Subjects with active serious mental illness, medical disorder or other symptoms/conditions that, in the opinion of the investigator, may affect treatment, compliance or the ability to provide informed consent.
研究组 & 干预措施
Arm A
Experimental
- STI-1558
- n=600
干预措施: STI-1558 (Drug)
Arm B
Placebo Comparator
- Placebo
- n=600
干预措施: STI-1558 placebo (Drug)
结局指标
主要结局
Time from the first dose to sustained recovery from 11 target symptoms of COVID-19.
时间窗: Time from the first dose to the day when the score of each of the 11 target symptoms of COVID-19 is 0.
Sustained recovery from 11 target symptoms of COVID-19: the score of each of the 11 target symptoms of COVID-19 in the subject is 0 for ≥2 days.
次要结局
- Time from the first dose to sustained recovery from 5 designated symptoms of COVID-19.(Time from the first dose to the day when the score of each of the 5 designated symptoms of COVID-19 is 0.)
- 1.Time to sustained recovery/sustained remission. 2.Proportion of subjects with sustained recovery/sustained remission. 3.Proportion of each of 11 target symptoms by severity. 4.Scores of 11 target symptoms -time AUC from the first dose to Day14.(From the first dose to Day29/Day14.)
- Change from baseline in the SARS-CoV-2 RNA load (reverse transcriptase polymerase chain reaction [RT-PCR] assay) at each visit point from the first dose to Day4 and Day6.(From the first dose to Day4 and Day6.)
- Proportion of subjects with negative SARS-CoV-2 RNA conversion at each visit from the first dose to Day14.(From the first dose to Day14.)
- Area under the SARS-CoV-2 RNA load-time curve (AUC) between the first dose and Day6.(From the first dose to Day6.)
- Proportion of subjects: 1.Progressing into severe COVID-19. 2.Undergoing COVID-19 associated hospitalization or all-cause deaths. 3.Requiring assisted oxygen inhalation/ mechanical ventilation/ECMO. 4.Admitted into the ICU. 5.Number of days in ICU.(From the first dose to Day29.)
- 1.Time from the first dose to sustained remission of 11 target symptoms of COVID-19. 2.Time from the first dose to sustained remission of 5 designated symptoms of COVID-19. 3.Time from the first dose to sustained remission of 14 symptoms of COVID-19.(From the first dose to the day when the score of each of the COVID-19 symptoms is 0 or 1.)
- During treatment: 1. Incidence of all adverse events (AEs) and serious adverse events (SAEs); 2. Any clinically significant abnormality in vital signs or physical examination; 3. Any clinically significant abnormality in laboratory tests, ECG, etc.(From the signing of informed consent to the 29 th day of administration.)
研究者
研究点 (2)
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