| Trial registration number
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JPRN-jRCT2041210004 |
Full text link
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCT2041210004
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First author
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Clinical Trial Information Officer
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Contact
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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fftc-clinicaltrial-info1@fujifilm.com
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Registration date
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-04-14
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Recruitment status
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1.Patients with positive SARS-CoV-2 test result by RT-PCR or loop-mediated isothermal amplification (LAMP) method or antigen test.2.Patient within 72 hours from onset of first COVID-19 symptom3.Patients with risk factors of progression to severe disease4.Have a negative pregnancy test before study treatment5.Patients can obtain written informed consent from the patients.6.Other
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Exclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1.Patients receiving oxygen therapy prior to the start of study treatment.2.Patients with any of COVID-19 clinical symptoms/findings of dyspnea or a respiratory rate of 30 breaths/min or more.3.Patients with SARS-CoV-2 vaccinated
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Number of arms
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Miyake Mamoru
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Inclusion age min
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild disease at enrollment
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Severity scale
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1: Mild disease at enrollment
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Total sample size
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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316
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primary outcome
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Percentage of patients with severe disease from randomization to Day 28
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Notes
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"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"}]
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