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

NCT ID: NCT04888949

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2023-05-18

Brief Summary

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

Detailed Description

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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.

Conditions

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SARS-CoV-2 Infection( COVID-19 )

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mesenchymal stem cell

4 times dose of Mesenchymal stem cell

Group Type EXPERIMENTAL

Mesenchymal stem cell

Intervention Type BIOLOGICAL

1\*10\^8 cells are administered once a week, total four times intravenously.

Placebo

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Commercially available saline.

Interventions

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Mesenchymal stem cell

1\*10\^8 cells are administered once a week, total four times intravenously.

Intervention Type BIOLOGICAL

Placebo

Commercially available saline.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rohto Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Okawa Sumito

Role: STUDY_DIRECTOR

Rohto Pharmaceutical Co., Ltd.

Locations

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Osaka University Hospital

Suita, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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ADR-001-1921

Identifier Type: -

Identifier Source: org_study_id

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