COVID-19
Conditions
Keywords
Novel coronavirus pneumonia, Favipiravir, Tocilizumab
Brief 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).
Interventions
DRUGFavipiravir 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.
DRUGFavipiravir
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.
DRUGTocilizumab
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.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate | 3 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of fever | 14 days after taking medicine |
| Lung imaging improvement time | 14 days after taking medicine |
| Viral nucleic acid test negative conversion rate and days from positive to negative | 14 days after taking medicine |
| Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs | 3 months |
| Mean in-hospital time | 3 months |
| Mortality rate because of Corona Virus Disease 2019 | 3 months |
Countries
China
Contacts
Primary ContactGuiqiang Wang
Backup ContactHong Zhao
Outcome results
None listed