Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
Latest Information Update: 08 Apr 2022
At a glance
- Drugs Favipiravir (Primary) ; Tocilizumab (Primary)
- Indications COVID 2019 infections; Pneumonia
- Focus Therapeutic Use
- 01 Jan 2021 Results published in the Biomedicine and Pharmacotherapy
- 26 Mar 2020 New trial record
Most Recent Events
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 | - |
| Pneumonia | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 150
Actual: 26
- Sex male & female
- Age Group 34-89 (median age 73) years; adult; elderly
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 |
|---|---|
| ChiCTR2000030894 | Chinese Clinical Trial Register |
| NCT04310228 | ClinicalTrials.gov: US National Institutes of Health |
| 2020YFC0844100 | - |
| 2020-056 | - |
| 2020YFC0846800 | - |
| 2017ZX10203202 | - |
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 IV
- 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.)
Results
Publications
-
Zhao H, Zhu Q, Zhang C, Li J, Wei M, Qin Y, et al. Tocilizumab combined with favipiravir in the treatment of COVID-19: A multicenter trial in a small sample size. Biomed-Pharmacother 2021;133110825.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Dingyu Zhang
13507117929
show details
|
Jinyintan Hospital of Wuhan | China |
|
Guiqiang Wang
13911405123
show details
john131212@sina.com |
Guiqiang Wang, Peking University First Hospital | China |
|
Haichao Li
18511129044
show details
|
Peking University First Hospital | China |
|
Hong Zhao
13810765943
show details
zhaohong_pufh@bjmu.edu.cn |
-
|
|
|
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 |
|---|---|---|
| 08 Apr 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Apr 2020). Updated 08 Apr 2022 |
| 08 Apr 2022 | Other trial event | Last checked against Clinicaltrials.gov record. Updated 08 Apr 2022 |
| 01 Jan 2021 | Results | Results published in the Biomedicine and Pharmacotherapy Updated 02 Feb 2021 |
| 23 Jun 2020 | Other trial event | New source identified and integrated Chinese Clinical Trial Register (ChiCTR2000030894). Updated 23 Jun 2020 |
| 26 Mar 2020 | New trial record | New trial record Updated 26 Mar 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Chinese Clinical Trial Register. Trial-Reg 2021;.
Available from: URL: http://www.chictr.org -
Zhao H, Zhu Q, Zhang C, Li J, Wei M, Qin Y, et al. Tocilizumab combined with favipiravir in the treatment of COVID-19: A multicenter trial in a small sample size. Biomed-Pharmacother 2021;133110825.
PubMed | CrossRef Fulltext
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