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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-08

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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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

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Favipiravir Combined With Tocilizumab

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Favipiravir

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Tocilizumab

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL