Back to resultsA Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
Primary Purpose
SARS-CoV-2 Infection( COVID-19 )
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Mesenchymal stem cell
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection( COVID-19 )
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
- 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
Sites / Locations
- Osaka University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mesenchymal stem cell
Placebo
Arm Description
4 times dose of Mesenchymal stem cell
Saline
Outcomes
Primary Outcome Measures
Ventilator Free Days
Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.
Secondary Outcome Measures
Full Information
NCT ID
NCT04888949
First Posted
May 9, 2021
Last Updated
October 25, 2022
Sponsor
Rohto Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04888949
Brief Title
A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
Official Title
An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
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
SARS-CoV-2 Infection( COVID-19 )
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stem cell
Arm Type
Experimental
Arm Description
4 times dose of Mesenchymal stem cell
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cell
Intervention Description
1*10^8 cells are administered once a week, total four times intravenously.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Commercially available saline.
Primary Outcome Measure Information:
Title
Ventilator Free Days
Description
Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.
Time Frame
Day 28
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rohto Pharmaceutical Co., Ltd.
Phone
+81-3-6823-6014
Email
adr-001@rohto.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Okawa Sumito
Organizational Affiliation
Rohto Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Fujino, MD
Phone
+81-3-6823-6014
Email
adr-001@rohto.co.jp
12. IPD Sharing Statement
Learn more about this trial
A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)
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