| Trial registration number
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JPRN-jRCT2053210023 |
Full text link
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCT2053210023
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First author
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Takayoshi Ono
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Contact
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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adr-001@rohto.co.jp
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Registration date
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-05-11
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Recruitment status
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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-SARS-CoV-2 infection is confirmed on antigen test or PCR test-Pulmonary infiltrative shadow is confirmed on chest X-ray test-Just after mechanical ventilation support start (equal to it would be possible to administer an Investigational Product to a subject within 72h from the mechanical ventilation support start)-PaO2/FiO2 <=200mmHg at the time of screening
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Exclusion criteria
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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-Continue Pneumonia before SARS-CoV-2 infection-SOFA score >= 15-Infection type on DIC diagnosis criteria >= 4-Deep Venous Thrombosis
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Number of arms
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Okawa Sumito
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Inclusion age min
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : July 16, 2021, 2 p.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 : July 16, 2021, 2 p.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 : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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primary outcome
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Ventilator Free Days (Time Frame: Day 28)
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Notes
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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Arms
Last imported at : July 16, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 36, "treatment_name": "Adr-001", "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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