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

ROHTO Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: SARS-CoV-2 Infection( COVID-19 )

Treatments: Biological: Mesenchymal stem cell; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04888949

ADR-001-1921

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Mesenchymal stem cell

Experimental group

Description:

4 times dose of Mesenchymal stem cell

Treatment:

Biological: Mesenchymal stem cell

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Biological: Placebo