NCT05689203招募中2 期
A Phase 2, 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
- 2 期
- 状态
- 招募中
- 入组人数
- 360
- 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 2 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 48 hours prior to randomization，first diagnosis of this infection within 72 hours prior to the randomization.
- •Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization，and at least 1 of the COVID-19-related symptoms/signs (Cough,Shortness of breath or difficulty breathing,fever,Chills,Body pain or muscle pain,Diarrhea,Nausea,Vomiting，Headache，Sore throat，Stuffy or runny nose)present on the day of randomization.
排除标准
- •Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
- •Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period (e.g. paxlovid, azvudine, etc.)
- •Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
- •Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
- •Has received any CYP3A4/2C8 strong inducer within 28 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
QLS1128 will be administered orally for 5 days.
干预措施: QLS1128 (Drug)
Placebo
Placebo Comparator
Placebo matching to QLS1128 will be administered orally for 5 days.
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
- Time to sustained alleviation of COVID-19 symptoms(Baseline through Day 29)
- Time to sustained recovery/ alleviation of each COVID-19 symptoms(Baseline through Day 29)
- Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms(Baseline through Day 29)
- Viral load(Baseline through Day 15)
- The time when the virus first turn negative and the proportion of patients that the virus turn negative(Baseline through Day 15)
- All-cause mortality, COVID-19 related mortality(Baseline through Day 29)
- The Adverse events(Baseline through Day 29)
研究者
研究点 (1)
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