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

Peking University

Status: Unknown

Conditions: COVID-19

Treatments: Drug: Favipiravir; Drug: Favipiravir Combined With Tocilizumab; Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04310228

2020YFC0844100

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

Favipiravir Combined With Tocilizumab group

Experimental group

Description:

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.

Treatment:

Drug: Favipiravir Combined With Tocilizumab

Favipiravir group

Active Comparator group

Description:

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.

Treatment:

Drug: Favipiravir

Tocilizumab group

Active Comparator group

Description:

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.

Treatment:

Drug: Tocilizumab