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Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04310228
Recruitment Status : Unknown
Verified April 2020 by Guiqiang Wang, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : March 17, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Favipiravir Combined With Tocilizumab Drug: Favipiravir Drug: Tocilizumab Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
Actual Study Start Date : March 8, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Favipiravir Combined With Tocilizumab group

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.

 Drug: Favipiravir Combined With Tocilizumab

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.
Active Comparator: Favipiravir group
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.
 Drug: 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.
Active Comparator: Tocilizumab group
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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical cure rate [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Viral nucleic acid test negative conversion rate and days from positive to negative [ Time Frame: 14 days after taking medicine ]
  2. Duration of fever [ Time Frame: 14 days after taking medicine ]
  3. Lung imaging improvement time [ Time Frame: 14 days after taking medicine ]
  4. Mortality rate because of Corona Virus Disease 2019 [ Time Frame: 3 months ]
  5. Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs [ Time Frame: 3 months ]
  6. Mean in-hospital time [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310228


Contacts
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Contact: Guiqiang Wang 13911405123 john131212@sina.com
Contact: Hong Zhao 13810765943 zhaohong_pufh@bjmu.edu.cn

Locations
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China, Beijing
Guiqiang Wang Recruiting
Beijing, Beijing, China, 100034
Contact: Guiqiang Wang    13911405123    john131212@sina.com   
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Haichao Li    18511129044      
China, Hubei
Ezhou Central Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Yuhong Qin    13810634388      
Huoshenshan Hospital of Wuhan Recruiting
Wuhan, Hubei, China, 430000
Contact: Qing Mao         
Jinyintan Hospital of Wuhan Recruiting
Wuhan, Hubei, China, 430000
Contact: Dingyu Zhang    13507117929      
Wuhan Pulmonary Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Xianxiang Chen    18971570937      
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Guiqiang Wang Peking University First Hospital
More Information
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Responsible Party: Guiqiang Wang, Principal Investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04310228    
Other Study ID Numbers: 2020YFC0844100
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guiqiang Wang, Peking University First Hospital:
Novel coronavirus pneumonia
Favipiravir
Tocilizumab
Additional relevant MeSH terms:
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Virus Diseases
Coronavirus Infections
COVID-19
Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Pneumonia, Viral
 Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Favipiravir
Antiviral Agents
Anti-Infective Agents