Status:
COMPLETED
An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection
Lead Sponsor:
Rohto Pharmaceutical Co., Ltd.
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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
- Mechanical ventilation is being utilized, or Acute Respiratory Failure whose PaO2 is not being achieved to 80 mmHg in spite of High-flow oxygen therapy
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 :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04522986
Start Date
August 21 2020
End Date
February 2 2021
Last Update
December 9 2024
Active Locations (1)
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1
Osaka University Hospital
Suita, Osaka, Japan, 565-0871