NCT04310228.

Study name	Favipiravir combined with tocilizumab in the treatment of coronavirus disease 2019
Methods	Randomized control trial
Participants	Inclusion criteria Clinically diagnosed with Coronavirus Disease 2019 Increased interleukin‐6 Sign the informed consent Can take medicine orally Agree to collect clinical samples Females 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 to 6 months. Males agree to effective contraception within 7 days of the last oral medication. Exclusion criteria Cases of severe vomiting that make it difficult to take the drug orally Allergic to favipiravir or tocilizumab Pregnant and lactating women Received specific antiviral drugs such as lopinavir/ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission Cases of respiratory failure and requiring mechanical ventilation Cases of shock Combined organ failure that requires ICU monitoring and treatment 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 Alanine aminotransferase/aspartate aminotransferase > 5 times the upper limit of normal Neutrophils < 0.5 × 10^9/L, platelets less than 50 × 10^9/L Clear diagnosis of rheumatoid immunity, malignant tumours, and other related diseases Long‐term oral anti‐rejection drugs or immunomodulatory drugs Allergic reactions to tocilizumab or any excipients Patients with active hepatitis, tuberculosis, and definite bacterial and fungal infections Organ transplant patients People with mental disorders
Interventions	Drug: favipiravir combined with tocilizumab Drug: favipiravir Drug: tocilizumab
Outcomes	Viral nucleic acid test negative conversion rate and days from positive to negative Duration of fever ‐ time frame: 14 days after taking medicine Lung imaging improvement time ‐ time frame: 14 days after taking medicine Mortality rate because of Coronavirus Disease 2019 ‐ time frame: 3 months Rate of non‐invasive or invasive mechanical ventilation when respiratory failure occurs ‐ time frame: 3 months Mean in‐hospital time ‐ time frame: 3 months
Starting date	08 March 2020
Contact information	Guiqiang Wang; Peking University First Hospital
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