Status:
UNKNOWN
Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019
Lead Sponsor:
Peking University First Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
NA
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, favipirav...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Patients with mental disorders
Key Trial Info
Start Date :
March 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04310228
Start Date
March 8 2020
End Date
May 1 2020
Last Update
April 10 2020
Active Locations (6)
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1
Guiqiang Wang
Beijing, Beijing Municipality, China, 100034
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
3
Ezhou Central Hospital
Wuhan, Hubei, China, 430000
4
Huoshenshan Hospital of Wuhan
Wuhan, Hubei, China, 430000