NCT05758519尚未招募3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,220
- 试验地点
- 1
- 主要终点
- Time to sustained recovery of COVID-19 symptoms
研究概览
简要总结
A Phase 3 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between ages of 18-80 years.
- •Confirmed SARS-CoV-2 infection as determined by RT-PCR or antigen test in any specimen collected within 120 hours prior to randomization.
- •Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization,and any of the following conditions are met on the day of randomization.
- •Score ≥2 for at least one symptom of body pain or muscle pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
- •Risk factors associated with progression to severe/critical COVID-19 with a score ≥1 for at least one symptom of fever,muscle or body pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
- •Score ≥1 for fever,with a score ≥1 for at least one symptom of muscle or body pain,headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
排除标准
- •Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
- •has received vaccines within 28 days prior to screening or planned to receive vaccines during the study period (including but not limited to COVID-19 vaccine).
- •Those who have a history of SARS-CoV-2 infection and still have symptoms related to COVID-19 during the screening period.
- •A history of SARS-CoV-2 infection, and the time of diagnosis of the latest infection to the time of diagnosis of the current infection is not more than 28 days.
- •Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period.
- •Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
- •Has received convalescent plasma therapy for COVID-19 patients or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
- •Has received any CYP3A4/2C8 strong inducer within 14 days prior to screening or plan to receive any CYP3A4/2C8 strong inducer during the study period.
- •A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure.
- •Allergic or have contraindications to test drugs or test drug excipients.
研究组 & 干预措施
QLS1128
Experimental
干预措施: QLS1128 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to sustained recovery of COVID-19 symptoms
时间窗: Baseline through Day 29
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days
次要结局
- Viral load(Baseline to Day 4)
- Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms(Baseline through Day 29)
- The time when the virus first turn negative(Baseline through Day 29)
- WHO 11-point ordinal scale(Baseline through Day 29)
- The Adverse events(Baseline through Day 29)
- Time to sustained alleviation of COVID-19 symptoms(Baseline through Day 29)
- All-cause mortality, COVID-19 related mortality(Baseline through Day 29)
- Time to sustained recovery/ alleviation of each COVID-19 symptoms(Baseline through Day 29)
研究者
研究点 (1)
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