The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
研究概览
简要总结
This is a randomized controlled clinical study on the clinical efficacy of Azvudine and Paxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is to examine the effect of high-risk on the time for COVID-19 patients to achieve 2 continuously negative SARS-CoV-2 nucleic acid test result, and the RT-PCR negative conversion rates in day 7. Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).
详细描述
After enrollment, patients will be randomized into treatment or control groups. Patients received Azvudine orally, for 7 consecutive days (7 doses in total) or Paxlovid orally for 5 consecutive days (10 doses in total). The test for RT-PCR test through either nasopharyngeal or oropharyngeal swabs were conducted on a daily basis from day 3 of their hospitalization until conversion was observed. The primary outcome was the proportion of patients acheive 2 continuously RT-PCR negative for SARS-CoV-2 at 7 days following treatment initiation, including both ORF gene Ct value≥35 and N gene Ct value≥35. Secondary outcomes included 1) the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days; 2) the time to conversion from a positive RT-PCR test to 2 continuously negative test; 3) 14-day treatment failure rate (need mechanical ventilation or high-flow oxygen therapy or death).
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
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-85 years (inclusive).
- •Meet the diagnostic criteria for COVID-
- •At least one high risk factor for progression to severe COVID-19
- •No more than 5 days from the onset of clinical symptoms
- •Sign informed consent form.
排除标准
- •Severe or critically patients with COVID-19
- •Have received neutralizing antibodies or convalescent plasma therapy due to COVID-19
- •Child-Pugh grade C or acute liver failure
- •Chronic renal failure (eGFR<30 mL/min)
- •Grade III or IV cardiac function, or known left ventricular ejection fraction < 30%
- •Known or suspected history of active or extrapulmonary tuberculosis
- •Patients who are allergic to the active ingredient of the drug
- •Pregnant and lactating women
研究组 & 干预措施
Azvudine group
Patients received Azvudine orally, for 7 consecutive days (7 doses in total) .
干预措施: Azvudine (Drug)
Paxlovid group
Patients received Paxlovid orally for 5 consecutive days (10 doses in total).
干预措施: Paxlovid group (Drug)
结局指标
主要结局
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
时间窗: 7 days after enrolled
the proportion of patients RT-PCR negative for SARS-CoV-2 at 7 days
次要结局
- the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days(14 days)
- the time to conversion from a positive RT-PCR test to 2 continuously negative test(14 days)
研究者
Songqiao Liu
MD. PhD.
Southeast University, China