SARS-CoV-2 Infection( COVID-19 )
Conditions
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.
Interventions
BIOLOGICALMesenchymal stem cell
1\*10\^8 cells are administered once a week, total four times intravenously.
BIOLOGICALPlacebo
Commercially available saline.
Sponsors
Rohto Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator Free Days | Day 28 | Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated. |
Countries
Japan
Outcome results
None listed