COVID-19NCT04310228
Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019
A study testing Favipiravir Combined With Tocilizumab, Favipiravir and Tocilizumab in people with COVID-19, run by Peking University First Hospital at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Favipiravir Combined With Tocilizumab, Favipiravir and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesChina
- Study dates
- 8 Mar 2020to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Guiqiang Wang
Beijing, Beijing Municipality, 100034
Guiqiang Wang, 13911405123, john131212@sina.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Haichao Li, 18511129044
- Recruiting
Ezhou Central Hospital
Wuhan, Hubei, 430000
Yuhong Qin, 13810634388
- Recruiting
Huoshenshan Hospital of Wuhan
Wuhan, Hubei, 430000
Qing Mao
- Recruiting
Jinyintan Hospital of Wuhan
Wuhan, Hubei, 430000
Dingyu Zhang, 13507117929
- Recruiting
Wuhan Pulmonary Hospital
Wuhan, Hubei, 430000
Xianxiang Chen, 18971570937
About this study
Official title: Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
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.
Read the 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).
- Conditions
- COVID-19
- Being tested
- Favipiravir Combined With Tocilizumab, Favipiravir, Tocilizumab
- Keywords
- Novel coronavirus pneumonia, Favipiravir, Tocilizumab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Favipiravir Combined With TocilizumabDrug
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.
FavipiravirDrug
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.
TocilizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir Combined With Tocilizumab group | Experimental | 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. Receives: Drug: Favipiravir Combined With Tocilizumab |
| Favipiravir group | Active comparator | 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. Receives: Drug: Favipiravir |
| Tocilizumab group | Active comparator | 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. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
Viral nucleic acid test negative conversion rate and days from positive to negative
Measured: 14 days after taking medicine
Duration of fever
Measured: 14 days after taking medicine
Lung imaging improvement time
Measured: 14 days after taking medicine
Mortality rate because of Corona Virus Disease 2019
Measured: 3 months
Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs
Measured: 3 months
Mean in-hospital time
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start8 Mar 2020
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guiqiang Wang, Peking University First Hospital
- Investigators
- Guiqiang Wang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310228
- Sponsor's protocol ID
- 2020YFC0844100
- Status last verified
- Apr 2020
- First submitted
- 9 Mar 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019-A Multicenter, Randomized and Controlled Clinical Trial Study
- ClinicalTrials.gov ID
- NCT04310228
- Acronym / sponsor ID
- 2020YFC0844100
- Conditions
- COVID-19
- Keywords
- Novel coronavirus pneumonia, Favipiravir, Tocilizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 8 Mar 2020 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Favipiravir Combined With Tocilizumab group | Experimental | Drug: Favipiravir Combined With TocilizumabFavipiravir: 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 | Active comparator | Drug: FavipiravirOn 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 | Active comparator | Drug: TocilizumabThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Favipiravir Combined With TocilizumabFavipiravir: 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 group |
| FavipiravirOn 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 group |
| TocilizumabThe 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 group |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiqiang Wang principal investigator
Peking University First Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Favipiravir Combined With Tocilizumab, Favipiravir and Tocilizumab in people with COVID-19, run by Peking University First Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guiqiang Wang (13911405123, john131212@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.