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NCT04522986 Clinical Trial

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

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial

— COVID-19  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04522986
Other study ID # ADR-001-1919
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 21, 2020
Est. completion date February 2, 2021

Study information
Verified date March 2021
Source Rohto Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date February 2, 2021
Est. primary completion date February 2, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Japan Osaka University Hospital Suita Osaka

Sponsors (1)
Lead Sponsor Collaborator
Rohto Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: Adverse Event Adverse events which appear in subjects with ADR-001 treatment are evaluated. 12 weeks
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