A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19)

November 17, 2023 updated by: Rohto Pharmaceutical Co., Ltd.

An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rohto Pharmaceutical Co., Ltd.
  • Phone Number: +81-3-6823-6014
  • Email: adr-001@rohto.co.jp

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Saline
Biological: Placebo
Commercially available saline.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator Free Days
Time Frame: Day 28
Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rohto Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Okawa Sumito, Rohto Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

May 18, 2023

Study Completion (Actual)

May 18, 2023

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 9, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADR-001-1921

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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