NCT04310228

Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019

Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Favipiravir Combined With Tocilizumab	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.
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.
DRUG	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.

Timeline

• Start date: 2020-03-08
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2020-03-17
• Last updated: 2020-04-10

Locations

6 sites across 1 country: China