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| Column | Value |
|---|---|
| Trial registration number | NCT04319900 |
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Full text link
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
shuminwang7000@163.com |
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Registration date
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2020-03-24 |
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Recruitment status
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - male and female, 18-75 years old - patients previously diagnosed with novel coronavirus pneumonia: the course of illness is no more than 14 days; if the course of the disease was more than 14 days, patient meets one of the following conditions can also be included in the group: (1) no apparent absorption or progression of chest radiograph was observed within 7 days; (2) respiratory symptoms (chest tightness, or cough, or breathing difficulties); (3) test for viral nucleic acid positive within 3 days. - informed consent should be signed by the participate or an authorized agent - agree to clinical samples collection - female or male subjects of childbearing age agree to take effective contraceptive measures within 3 months of the last oral medication to ensure that female or male partners of childbearing age do not become pregnant |
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Exclusion criteria
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- severe vomiting or difficulty ingesting medication - woman who are pregnant or during lactation - patients received lopinavir/ridonavir, ribavirin, interferon and monoclonal antibody specific antiviral drugs three days before enrollment - cases of respiratory failure requiring mechanical ventilation - shock - combined with other organ failure and requires icu care - clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission |
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Number of arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Beijing Chao Yang Hospital |
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Inclusion age min
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
75 |
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Countries
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
150 |
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primary outcome
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Frequency of Improvement or recovery of respiratory symptoms;Number of days virus nucleic acid shedding;Time of Improvement or recovery of respiratory symptoms |
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Notes
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : May 22, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1456, "treatment_name": "Chloroquine+favipiravir", "treatment_type": "Antimalarials+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |