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| Column | Value |
|---|---|
| Trial registration number | NCT04310228 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
john131212@sina.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-03-17 |
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Recruitment status
Last imported at : April 5, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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 |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Peking University First Hospital |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
65 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
150 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Clinical cure rate |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Duplicate ChiCTR2000030894", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Duplicate ChiCTR2000030894", "treatment_id": 1517, "treatment_name": "Favipiravir+tocilizumab", "treatment_type": "Antivirals+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Duplicate ChiCTR2000030894", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}] |