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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522986
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 Biological: Mesenchymal stem cell 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Actual Primary Completion Date : February 2, 2021
Actual Study Completion Date : February 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Mesenchymal stem cell
4 times dose of Mesenchymal stem cell
Biological: Mesenchymal stem cell
1*10^8 cells are administered once a week, total four times intravenously.




Primary Outcome Measures :
  1. Safety: Adverse Event [ Time Frame: 12 weeks ]
    Adverse events which appear in subjects with ADR-001 treatment are evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522986


Locations
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Japan
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Rohto Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Yuji Fujino, MD Osaka University Hospital
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Responsible Party: Rohto Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04522986    
Other Study ID Numbers: ADR-001-1919
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
COVID-19
Severe Acute Respiratory Syndrome
Infections
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Pneumonia, Viral