Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study

Trial Profile

Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Apr 2020

At a glance

  • Drugs Favipiravir (Primary) ; Tocilizumab (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 26 Mar 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

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

Other Endpoints

Viral nucleic acid test negative conversion rate and days from positive to negative

time_frame: 14 days after taking medicine

Duration of fever

time_frame: 14 days after taking medicine

Lung imaging improvement time

time_frame: 14 days after taking medicine

Mortality rate because of Corona Virus Disease 2019

time_frame: 3 months

Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs

time_frame: 3 months

Mean in-hospital time

time_frame: 3 months [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 150

  • Sex male & female
  • Age Group 18-65 years; adult

Patient 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.

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04310228 ClinicalTrials.gov: US National Institutes of Health
2020YFC0844100 -

Trial Dates

  • Initiation Dates

    Actual : 08 Mar 2020

  • Primary Completion Dates

    Planned : 01 May 2020

  • End Dates

    Planned : 01 May 2020

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
FavipiravirPrimary Drug Oral Tablet
TocilizumabPrimary Drug Intravenous Infusion

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.)

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.)

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.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Dingyu Zhang
13507117929
show details
Jinyintan Hospital of Wuhan China
Guiqiang Wang
13911405123
john131212@sina.com
show details
Guiqiang Wang, Peking University First Hospital China
Haichao Li
18511129044
show details
Peking University First Hospital China
Hong Zhao
13810765943
zhaohong_pufh@bjmu.edu.cn
show details
-
Qin Ning
13971521450
show details
Tongji Hospital of Huazhong University of Science and Technology China
Qing Mao Huoshenshan Hospital of Wuhan China
Xi Zheng
18602724981
show details
Cancer Hospital Union Hospital Tongji Medical College Huazhong University of Science and Technology China
Xianxiang Chen
18971570937
show details
Wuhan Pulmonary Hospital China
Xihai Xu
13966658330
show details
Anhui Medical University Affiliated First Hospital China
Yu Hu
13986183871
show details
West Hospital Union Hospital Huazhong University of Science and Technology China
Yuhong Qin
13810634388
show details
Ezhou Central Hospital China
Zhenshun Cheng
13627288300
show details
Zhongnan Hospital of Wuhan University China

Centres

Centre Name Location Trial Centre Country
-
-
-
Anhui Medical University Affiliated First Hospital Hefei, Anhui China
Cancer Hospital Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, Hubei China
Ezhou Central Hospital Wuhan, Hubei China
Guiqiang Wang Beijing, Beijing China
Huoshenshan Hospital of Wuhan Wuhan, Hubei China
Jinyintan Hospital of Wuhan Wuhan, Hubei China
Peking University First Hospital
-
-
Peking University First Hospital Beijing, Beijing China
Tongji Hospital of Huazhong University of Science and Technology Wuhan, Hubei China
West Hospital Union Hospital Huazhong University of Science and Technology Wuhan, Hubei China
Wuhan Pulmonary Hospital Wuhan, Hubei China
Zhongnan Hospital of Wuhan University Wuhan, Hubei China

Trial History

Event Date Event Type Comment
11 Apr 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 11 Apr 2020
26 Mar 2020 New trial record New trial record Updated 26 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
Back to top