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

Phase 2

Completed

• Conditions: SARS-CoV-2 Infection( COVID-19 )
• Interventions: Biological: Mesenchymal stem cell; Biological: Placebo

• Registration Number: NCT04888949
• Lead Sponsor: Rohto Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-09
• Study First Posted: 2021-05-17
• Study Start: 2021-06-15
• Primary Completion: 2023-05-18
• Study Completion: 2023-05-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

• Continue treatment for Pneumonia before SARS-CoV-2 infection
• SOFA score >= 15
• Infection type on DIC diagnosis criteria >= 4
• Deep Venous Thrombosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cell	Mesenchymal stem cell	4 times dose of Mesenchymal stem cell
Placebo	Placebo	Saline

Primary Outcome Measures

Name	Time	Method
Ventilator Free Days	Day 28	Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan