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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310228
• Other study ID #: 2020YFC0844100
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2020
• Est. completion date: May 2020

Study information

• Verified date: April 2020
• Source: Peking University First Hospital
• Contact: Guiqiang Wang
• Phone: 13911405123
• Email: john131212[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Clinically diagnosed with Corona Virus Disease 2019

2. Increased interleukin-6

3. Sign the informed consent

4. Subjects who can take medicine orally

5. Agree to collect clinical samples

6. 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

7. Male patients agree to effective contraception within 7 days of last oral medication.

Exclusion Criteria:

1. Cases of severe vomiting that make it difficult to take the drug orally

2. Allergic to Favipiravir or tocilizumab

3. Pregnant and lactating women

4. Subjects received specific antiviral drugs such as lopinavir / ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission.

5. Cases of respiratory failure and requiring mechanical ventilation

6. Cases of shock

7. Combined organ failure requires ICU monitoring and treatment

8. 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

9. Alanine aminotransferase / Aspartate aminotransferase> 5 times of upper limit of normal

10. Neutrophils <0.5 × 10^9 / L, platelets less than 50 × 10^9 / L

11. Clear diagnosis of rheumatoid immunity, malignant tumors and other related diseases

12. Long-term oral anti-rejection drugs or immunomodulatory drugs

13. Allergic reactions to tocilizumab or any excipients

14. Patients with active hepatitis, tuberculosis, and definite bacterial and fungal infections

15. Organ transplant patients

16. Patients with mental disorders

Related Conditions & MeSH terms

• COVID-19
• Virus Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guiqiang Wang	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Ezhou Central Hospital	Wuhan	Hubei
China	Huoshenshan Hospital of Wuhan	Wuhan	Hubei
China	Jinyintan Hospital of Wuhan	Wuhan	Hubei
China	Wuhan Pulmonary Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Viral nucleic acid test negative conversion rate and days from positive to negative		14 days after taking medicine
Secondary	Duration of fever		14 days after taking medicine
Secondary	Lung imaging improvement time		14 days after taking medicine
Secondary	Mortality rate because of Corona Virus Disease 2019		3 months
Secondary	Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs		3 months
Secondary	Mean in-hospital time		3 months