Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019
1 other identifier
interventional
150
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Mar 2020
Shorter than P25 for not_applicable covid19
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2020
CompletedFirst Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedApril 10, 2020
April 1, 2020
2 months
March 9, 2020
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical cure rate
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.
3 months
Secondary Outcomes (6)
Viral nucleic acid test negative conversion rate and days from positive to negative
14 days after taking medicine
Duration of fever
14 days after taking medicine
Lung imaging improvement time
14 days after taking medicine
Mortality rate because of Corona Virus Disease 2019
3 months
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs
3 months
- +1 more secondary outcomes
Study Arms (3)
Favipiravir Combined With Tocilizumab group
EXPERIMENTALFavipiravir: 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
ACTIVE COMPARATOROn 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
ACTIVE COMPARATORThe 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
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Clinically diagnosed with Corona Virus Disease 2019
- Increased interleukin-6
- Sign the informed consent
- Subjects who can take medicine orally
- Agree to collect clinical samples
- 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
- Male patients agree to effective contraception within 7 days of last oral medication.
You may not qualify if:
- Cases of severe vomiting that make it difficult to take the drug orally
- Allergic to Favipiravir or tocilizumab
- Pregnant and lactating women
- Subjects 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 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 of upper limit of normal
- Neutrophils \<0.5 × 10\^9 / L, platelets less than 50 × 10\^9 / L
- Clear diagnosis of rheumatoid immunity, malignant tumors 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Guiqiang Wang
Beijing, Beijing Municipality, 100034, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Ezhou Central Hospital
Wuhan, Hubei, 430000, China
Huoshenshan Hospital of Wuhan
Wuhan, Hubei, 430000, China
Jinyintan Hospital of Wuhan
Wuhan, Hubei, 430000, China
Wuhan Pulmonary Hospital
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guiqiang Wang
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 9, 2020
First Posted
March 17, 2020
Study Start
March 8, 2020
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
April 10, 2020
Record last verified: 2020-04