NCT04888949CompletedPhase 2
An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Rohto Pharmaceutical Co., Ltd.1 site in 1 country15 target enrollmentStarted: June 15, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Ventilator Free Days
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Saline
Intervention: Placebo (Biological)
Mesenchymal stem cell
Experimental
4 times dose of Mesenchymal stem cell
Intervention: Mesenchymal stem cell (Biological)
Outcomes
Primary Outcomes
Ventilator Free Days
Time Frame: Day 28
Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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