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NCT04522986 | Completed | Severe Acute Respiratory Syndrome Coronavirus 2

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

Condition or disease

Severe Acute Respiratory Syndrome Coronavirus 2

Intervention/treatment

Mesenchymal stem cell

Phase

Phase 1

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 Type : Interventional
Estimated Enrollment : 6 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Actual Study Start Date : August 21, 2020
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : February 2, 2021
Arm Intervention/treatment

Experimental: Mesenchymal stem cell

4 times dose of Mesenchymal stem cell

Biological: Mesenchymal stem cell
Ages Eligible for Study: 20 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • SARS-CoV-2 infection is confirmed on antigen test or PCR test
  • Pulmonary infiltrative shadow is confirmed on chest X-ray test
  • Mechanical ventilation is being utilized, or Acute Respiratory Failure whose PaO2 is not being achieved to 80 mmHg in spite of High-flow oxygen therapy
Exclusion Criteria
  • Continue treatment for Pneumonia before SARS-CoV-2 infection
  • SOFA score >= 15
  • Infection type on DIC diagnosis criteria >= 4
  • Deep Venous Thrombosis
An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection

Location Details

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

How to Participate

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Locations

Not yet recruiting

Japan, Osaka

Osaka University Hospital

Suite, Osaka, Japan, 565-0871