Back to resultsAn Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
Primary Purpose
Severe Acute Respiratory Syndrome Coronavirus 2
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Mesenchymal stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Continue treatment for Pneumonia before SARS-CoV-2 infection
- SOFA score >= 15
- Infection type on DIC diagnosis criteria >= 4
- Deep Venous Thrombosis
Sites / Locations
- Osaka University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mesenchymal stem cell
Arm Description
4 times dose of Mesenchymal stem cell
Outcomes
Primary Outcome Measures
Safety: Adverse Event
Adverse events which appear in subjects with ADR-001 treatment are evaluated.
Secondary Outcome Measures
Full Information
NCT ID
NCT04522986
First Posted
August 20, 2020
Last Updated
March 16, 2021
Sponsor
Rohto Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04522986
Brief Title
An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Acronym
COVID-19
Official Title
An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rohto Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome Coronavirus 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stem cell
Arm Type
Experimental
Arm Description
4 times dose of Mesenchymal stem cell
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cell
Intervention Description
1*10^8 cells are administered once a week, total four times intravenously.
Primary Outcome Measure Information:
Title
Safety: Adverse Event
Description
Adverse events which appear in subjects with ADR-001 treatment are evaluated.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Continue treatment for Pneumonia before SARS-CoV-2 infection
SOFA score >= 15
Infection type on DIC diagnosis criteria >= 4
Deep Venous Thrombosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Fujino, MD
Organizational Affiliation
Osaka University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
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