Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Clinical cure rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.
详细描述
In clinical institutions that enroll patients with corona virus disease 2019, three arms, multi-center, randomized and controlled methods are adopted. Patients are divided into three groups, favipiravir combined with tocilizumab group, favipiravir group and tocilizumab group. 150 patients are expected to be enrolled and the cases are allocated according to the ratio of 3( favipiravir combined with tocilizumab group): 1(favipiravir group): 1(tocilizumab group).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with Corona Virus Disease 2019
- •Increased interleukin-6
- •Sign the informed consent
- •Subjects who can take medicine orally
- •Agree to collect clinical samples
- •Female subjects of childbearing age are not pregnant and agree to take effective contraception within 7 days of the last oral medication to ensure that they are not pregnant within 3-6 months
- •Male patients agree to effective contraception within 7 days of last oral medication.
排除标准
- •Cases of severe vomiting that make it difficult to take the drug orally
- •Allergic to Favipiravir or tocilizumab
- •Pregnant and lactating women
- •Subjects received specific antiviral drugs such as lopinavir / ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission.
- •Cases of respiratory failure and requiring mechanical ventilation
- •Cases of shock
- •Combined organ failure requires ICU monitoring and treatment
- •Predicted clinically that there is no hope of survival, or cases of deep coma that do not respond to supportive treatment measures within three hours of admission
- •Alanine aminotransferase / Aspartate aminotransferase> 5 times of upper limit of normal
- •Neutrophils <0.5 × 10^9 / L, platelets less than 50 × 10^9 / L
- •Clear diagnosis of rheumatoid immunity, malignant tumors and other related diseases
- •Long-term oral anti-rejection drugs or immunomodulatory drugs
- •Allergic reactions to tocilizumab or any excipients
- •Patients with active hepatitis, tuberculosis, and definite bacterial and fungal infections
- •Organ transplant patients
- •Patients with mental disorders
研究组 & 干预措施
Favipiravir Combined With Tocilizumab group
Favipiravir: On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 7 days.
Tocilizumab:The first dose is 4 ~ 8mg/kg and the recommended dose is 400mg. For fever patients, an additional application (the same dose as before) is given if there is still fever within 24 hours after the first dose and the interval between two medications ≥ 12 hours.Intravenous infusion, The maximum of cumulative number is two, and the maximum single dose does not exceed 800mg.
干预措施: Favipiravir Combined With Tocilizumab (Drug)
Favipiravir group
On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 7 days.
干预措施: Favipiravir (Drug)
Tocilizumab group
The first dose is 4 ~ 8mg/kg and the recommended dose is 400mg. For fever patients, an additional application (the same dose as before) is given if there is still fever within 24 hours after the first dose and the interval between two medications ≥ 12 hours.Intravenous infusion, The maximum of cumulative number is two, and the maximum single dose does not exceed 800mg.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Clinical cure rate
时间窗: 3 months
Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
次要结局
- Duration of fever(14 days after taking medicine)
- Viral nucleic acid test negative conversion rate and days from positive to negative(14 days after taking medicine)
- Mean in-hospital time(3 months)
- Lung imaging improvement time(14 days after taking medicine)
- Mortality rate because of Corona Virus Disease 2019(3 months)
- Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs(3 months)
研究者
Guiqiang Wang
Principal Investigator
Peking University First Hospital