A Prospective Multicenter, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Azvudine vs. Nirmatrelvir-Ritonavir in Hospitalized Patients With Moderate to Severe COVID-19 Infection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Time and proportion of patients with COVID-19 infection to have sustained clinical recovery
研究概览
简要总结
The COVID-19 pandemic has become a major public health challenge, and the treatment options for the disease are currently limited. The commonly used oral small-molecule anti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. These drugs have been tested in pre-marketing clinical trials in patients with non-severe COVID-19 infection and have demonstrated therapeutic effects in inhibiting virus transmission and preventing disease progression. However, until now, the efficacy and safety of these drugs in patients with moderate to severe COVID-19 infections remains unclear. Therefore, this study is aiming to compare the efficacy and safety of Azvudine and Nirmatrelvir-Ritonavir in moderate to severe COVID-19 infections. This study will be a multicenter, randomized, controlled clinical trial study in patients hospitalized with moderate to severe COVID-19 infections. Recovery of clinical symptoms, nucleic acid negative conversion, improvement in oxygenation index, and imaging improvement will be used as study endpoints.
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
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
- •Hospitalized patients of ≥18 years old, regardless of gender or race;
- •Patients who have a positive SARS-CoV-2 test result;
- •Diagnosed with moderate or severe COVID-19 infection according to the diagnostic criteria from the "Diagnosis and treatment program trial version 10 guidelines" issued by the National Health Commission of the People's Republic of China. Including:
- •①Moderate: continuous high fever for more than 3 days or/and cough, shortness of breath, etc., but the breathing frequency (RR) is less than 30 times/minute, and the oxygen saturation when inhaling air at rest is > 93%. Imaging shows the characteristic manifestations of COVID-19 pneumonia.
- •② Severe: Adults meet any of the following requirements: A, shortness of breath, RR≥ 30 times/minute; B, the oxygen saturation when inhaling air at rest is ≤ 93%; C, Arterial partial oxygen pressure (PaO2)/ Fraction of inspiration O2 (FiO2) ≤300mmHg (1mmHg=0.133kPa), and PaO2/FiO2 should be corrected according to the following formula for areas above 1000 m :PaO2/FiO2× [760/ atmospheric pressure (mmHg)]; D, the clinical symptoms were gradually aggravated, and the lung imaging showed that the lesion progressed significantly within 24 ~ 48 hours > 50%.
- •Join this study voluntarily.
- •Each subject must sign an informed consent form (ICF) indicating that he/she understands the purpose and procedure of the study and is willing to participate in the study. Considering the patient's condition, the ICF may be signed by the legal representative.
排除标准
- •Allergic to the drugs involved;
- •Pregnancy or lactation;
- •Diagnosed or suspected critical COVID-19 infection;
- •Child-Pugh C of liver function or estimated glomerular filtration rate (eGFR) less than 30mL/min during screening;
- •Receive SARS-CoV-2 monoclonal antibody therapy or other antiviral therapy;
- •The subject and/or authorized family members refused to receive anti-COVID-19 treatment;
- •Any life-threatening disease or organ system dysfunction that the researcher thinks can harm the safety of the subjects and expose the research results to unnecessary risks; drug addicts, uncontrolled mental illness or cognitive dysfunction.
- •Join other similar clinical researchers within 3 months;
- •Patients who were not considered suitable for inclusion by the researchers (such as patients who were expected to be unable to adhere to the treatment due to financial problems).
研究组 & 干预措施
Azvudine
干预措施: Azvudine (Drug)
Nirmatrelvir-Ritonavir
干预措施: Nirmatrelvir-Ritonavir (Drug)
结局指标
主要结局
Time and proportion of patients with COVID-19 infection to have sustained clinical recovery
时间窗: Up to 28 days
次要结局
- Time and proportion of the nucleic acid negative conversion(Days 3, 6, 9, 12, 15, 18, 21, 24, 27)
- Proportion of progression to critical COVID-19 and death from any cause(Up to 28 days)
- Time and proportion of chest CT image improvement(Days 6, 12, 18, 24)
- Time and proportion of oxygenation index improvement(Up to 28 days)
- Length of stay(Up to 28 days)
- Time of COVID-19 related symptom score and World Health Organization (WHO) clinical progress scale score. Time and proportion of clinical recovery, symptom resolution and regression of major symptoms(Up to 28 days)
研究者
Jia-jun Zhao
Director
Shandong Provincial Hospital