| Trial registration number
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NCT04888949 |
Full text link
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04888949
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First author
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Rohto Pharmaceutical Co., Ltd.
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Contact
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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adr-001@rohto.co.jp
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Registration date
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-05-17
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Recruitment status
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- sars-cov-2 infection is confirmed on antigen test or pcr test
- pulmonary infiltrative shadow is confirmed on chest x-ray test
- pao2/fio2 <=200mmhg at the time of screening
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Exclusion criteria
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- continue treatment for 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 : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Rohto Pharmaceutical Co., Ltd.
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Inclusion age min
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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20
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Inclusion age max
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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Japan
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Type of patients
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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20
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primary outcome
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Ventilator Free Days
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Notes
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 788, "treatment_name": "Mesenchymal stem cells exosomes", "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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