NCT04522986

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

August 20, 2020

Last Update Submit

December 4, 2024

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Outcome Measures

Primary Outcomes (1)

  • Safety: Adverse Event

    Adverse events which appear in subjects with ADR-001 treatment are evaluated.

    12 weeks

Study Arms (1)

Mesenchymal stem cell

EXPERIMENTAL

4 times dose of Mesenchymal stem cell

Biological: Mesenchymal stem cell

Interventions

Mesenchymal stem cellBIOLOGICAL

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

Mesenchymal stem cell

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Continue treatment for Pneumonia before SARS-CoV-2 infection
  • SOFA score \>= 15
  • Infection type on DIC diagnosis criteria \>= 4
  • Deep Venous Thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Study Officials

  • Yuji Fujino, MD

    Osaka University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 21, 2020

Study Start

August 21, 2020

Primary Completion

February 2, 2021

Study Completion

February 2, 2021

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)