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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favipiravir Combined With Tocilizumab group | Experimental | 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. |
|
| Favipiravir group | Active Comparator | 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 group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir Combined With Tocilizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Viral nucleic acid test negative conversion rate and days from positive to negative | 14 days after taking medicine | |
| Duration of fever | 14 days after taking medicine | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiqiang Wang | Contact | 13911405123 | john131212@sina.com | |
| Hong Zhao | Contact | 13810765943 | zhaohong_pufh@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guiqiang Wang | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| C462182 | favipiravir |
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| Favipiravir | Drug | 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 | Drug | 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. |
|
| 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 |
| Mean in-hospital time | 3 months |
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
|
| Ezhou Central Hospital | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Huoshenshan Hospital of Wuhan | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Jinyintan Hospital of Wuhan | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Wuhan Pulmonary Hospital | Recruiting | Wuhan | Hubei | 430000 | China |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |