Status:
COMPLETED
A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
Lead Sponsor:
Rohto Pharmaceutical Co., Ltd.
Conditions:
SARS-CoV-2 Infection( COVID-19 )
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.
Detailed Description
Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Continue treatment for Pneumonia before SARS-CoV-2 infection
- SOFA score \>= 15
- Infection type on DIC diagnosis criteria \>= 4
- Deep Venous Thrombosis
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04888949
Start Date
June 15 2021
End Date
May 18 2023
Last Update
November 18 2023
Active Locations (1)
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1
Osaka University Hospital
Suita, Osaka, Japan, 565-0871