A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
NCT ID: NCT04888949
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2021-06-15
2023-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mesenchymal stem cell
4 times dose of Mesenchymal stem cell
Mesenchymal stem cell
1\*10\^8 cells are administered once a week, total four times intravenously.
Placebo
Saline
Placebo
Commercially available saline.
Interventions
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Mesenchymal stem cell
1\*10\^8 cells are administered once a week, total four times intravenously.
Placebo
Commercially available saline.
Eligibility Criteria
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Inclusion Criteria
* Pulmonary infiltrative shadow is confirmed on chest X-ray test
* PaO2/FiO2 \<=200mmHg at the time of screening
Exclusion Criteria
* SOFA score \>= 15
* Infection type on DIC diagnosis criteria \>= 4
* Deep Venous Thrombosis
20 Years
ALL
No
Sponsors
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Rohto Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Okawa Sumito
Role: STUDY_DIRECTOR
Rohto Pharmaceutical Co., Ltd.
Locations
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Osaka University Hospital
Suita, Osaka, Japan
Countries
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Other Identifiers
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ADR-001-1921
Identifier Type: -
Identifier Source: org_study_id
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