COVID-19: An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection

Sponsor
Rohto Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04522986
Collaborator
(none)
6
1
1
5.4
1.1

Study Details

Study Description

Brief Summary

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Condition or Disease Intervention/Treatment Phase
  • Biological: Mesenchymal stem cell
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Actual Study Start Date :
Aug 21, 2020
Actual Primary Completion Date :
Feb 2, 2021
Actual Study Completion Date :
Feb 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mesenchymal stem cell

4 times dose of Mesenchymal stem cell

Biological: Mesenchymal stem cell
1*10^8 cells are administered once a week, total four times intravenously.

Outcome Measures

Primary Outcome Measures

  1. Safety: Adverse Event [12 weeks]

    Adverse events which appear in subjects with ADR-001 treatment are evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Osaka University Hospital Suita Osaka Japan 565-0871

Sponsors and Collaborators

  • Rohto Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Yuji Fujino, MD, Osaka University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rohto Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04522986
Other Study ID Numbers:
  • ADR-001-1919
First Posted:
Aug 21, 2020
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021