Clinical trial NCT04310228: Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019
Official title: Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Novel coronavirus pneumonia
Favipiravir
Tocilizumab
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Clinical cure rate
timeFrame: 3 months
Secondary outcomes:
measure: Viral nucleic acid test negative conversion rate and days from positive to negative
timeFrame: 14 days after taking medicine
measure: Duration of fever
timeFrame: 14 days after taking medicine
measure: Lung imaging improvement time
timeFrame: 14 days after taking medicine
measure: Mortality rate because of Corona Virus Disease 2019
timeFrame: 3 months
measure: Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs
timeFrame: 3 months
measure: Mean in-hospital time
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guiqiang Wang
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Wuhan
country: China
facility: Ezhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Huoshenshan Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Jinyintan Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Wuhan Pulmonary Hospital
state: Hubei
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang
role: PRINCIPAL_INVESTIGATOR
References: