search
Back to results

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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Favipiravir Combined With Tocilizumab
Favipiravir
Tocilizumab
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Novel coronavirus pneumonia, Favipiravir, Tocilizumab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guiqiang WangRecruiting
  • Peking University First HospitalRecruiting
  • Ezhou Central HospitalRecruiting
  • Huoshenshan Hospital of WuhanRecruiting
  • Jinyintan Hospital of WuhanRecruiting
  • Wuhan Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Favipiravir Combined With Tocilizumab group

Favipiravir group

Tocilizumab group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Viral nucleic acid test negative conversion rate and days from positive to negative
Duration of fever
Lung imaging improvement time
Mortality rate because of Corona Virus Disease 2019
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs
Mean in-hospital time

Full Information

First Posted
March 9, 2020
Last Updated
April 8, 2020
Sponsor
Peking University First Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04310228
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2020 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Novel coronavirus pneumonia, Favipiravir, Tocilizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Favipiravir Combined With Tocilizumab group
Arm Type
Experimental
Arm Description
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.
Arm Title
Favipiravir group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tocilizumab group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Favipiravir Combined With Tocilizumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Favipiravir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical cure rate
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Viral nucleic acid test negative conversion rate and days from positive to negative
Time Frame
14 days after taking medicine
Title
Duration of fever
Time Frame
14 days after taking medicine
Title
Lung imaging improvement time
Time Frame
14 days after taking medicine
Title
Mortality rate because of Corona Virus Disease 2019
Time Frame
3 months
Title
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs
Time Frame
3 months
Title
Mean in-hospital time
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guiqiang Wang
Phone
13911405123
Email
john131212@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Zhao
Phone
13810765943
Email
zhaohong_pufh@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guiqiang Wang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Phone
13911405123
Email
john131212@sina.com
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haichao Li
Phone
18511129044
Facility Name
Ezhou Central Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhong Qin
Phone
13810634388
Facility Name
Huoshenshan Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Mao
Facility Name
Jinyintan Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingyu Zhang
Phone
13507117929
Facility Name
Wuhan Pulmonary Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianxiang Chen
Phone
18971570937

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs