A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
Phase 2
Completed
- Conditions
- SARS-CoV-2 Infection( COVID-19 )
- Registration Number
- NCT04888949
- Lead Sponsor
- Rohto Pharmaceutical Co., Ltd.
- 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. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Exclusion Criteria
- Continue treatment for Pneumonia before SARS-CoV-2 infection
- SOFA score >= 15
- Infection type on DIC diagnosis criteria >= 4
- Deep Venous Thrombosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ventilator Free Days Day 28 Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Osaka University Hospital🇯🇵Suita, Osaka, Japan