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

Rohto Pharmaceutical Co., Ltd.15 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

SARS-CoV-2 Infection( COVID-19 )

Interventions

Mesenchymal stem cellBIOLOGICAL

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

PlaceboBIOLOGICAL

Commercially available saline.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Osaka University Hospital

Suita, Osaka, Japan

Outcomes

Primary Outcomes

Ventilator Free Days

Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.

Time frame: Day 28

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.