| Trial registration number
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JPRN-jRCT2043210005 |
Full text link
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCT2043210005
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First author
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Clinical Trials Information Desk -
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Contact
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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lsii.chiken-inq@eppharmaline.co.jp
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Registration date
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-04-21
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Recruitment status
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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-SARS-CoV-2 positive patients by RT-PCR-Patients diagnosed with ARDS by Berlin definition-Patients who are intubated and under mechanical ventilatory control
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Exclusion criteria
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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-Patients managed by Extracorporeal Membrane Oxygenation (ECMO) or using ventilation techniques such as High Frequency Oscillatory Ventilation (HFOV)-Patients who are not expected to survive for about 72 hours
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Number of arms
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : July 7, 2022, 1:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Takase Kiyoshi
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Inclusion age min
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Critical disease at enrollment
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Severity scale
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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8: Critical disease at enrollment
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Total sample size
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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43
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primary outcome
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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STEP 1 : Safety as measured by incidence of Adverse events (AEs); adverse drug reactions (ADRs)STEP 2 : Efficacy as measured by mortality up to 4 weeks after administration
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Notes
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Nov. 13, 2021, 5:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 1/Phase 2
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Arms
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1968, "treatment_name": "Cl2020", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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