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OpenTrials
Completed

NCT Number: NCT04888949

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

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

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Key information

Conditions

SARS-CoV-2 Infection( COVID-19 )

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal stem cell

Biological

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

Placebo

Biological

Commercially available saline.

Primary outcomes

  1. Ventilator Free Days

    Time frame: Day 28

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

Sponsors and collaborators

Lead sponsor

Rohto Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 17, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.