Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Group 1:Favipiravir Combined With Tocilizumab
Group 2:Favipiravir
Group 3:Tocilizumab
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18-65 years; 2. Clinically diagnosed with Corona Virus Disease 2019; 3. Increased interleukin-6; 4. Sign the informed consent; 5. Subjects who can take medicine orally; 6. Agree to collect clinical samples; 7. 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; 8. Male patients agree to effective contraception within 7 days of last oral medication.
Exclusion criteria
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 x 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 |
|---|---|
| Clinical cure rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral nucleic acid test negative conversion rate and days from positive to negative;Duration of fever;Lung imaging improvement time;Mortality rate because of Corona Virus Disease 2019;Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs;Mean in-hospital time;concentration of C-reactive protein;lymphocyte absolute value and its percentage; | — |
Countries
China
Contacts
Public ContactGuiqiang Wang
Peking University First Hospital
Outcome results
None listed