A Study of ADR-001 in Patients With Severe Pneumonia Caus... | NCT04888949

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

NCT04888949

Sponsor

Rohto Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

15Actual

Phase

Phase 2

Conditions

SARS-CoV-2 Infection( COVID-19 )

Interventions

Mesenchymal stem cell
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2021Actual

Primary Completion Date

May 18, 2023Actual

Completion Date

May 18, 2023Actual

First Submitted Date

May 9, 2021

First Submission Date that Met QC Criteria

May 9, 2021

First Posted Date

May 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenchymal stem cell	Experimental	4 times dose of Mesenchymal stem cell	Biological: Mesenchymal stem cell
Placebo	Placebo Comparator	Saline	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal stem cell	Biological	1*10^8 cells are administered once a week, total four times intravenously.	Mesenchymal stem cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ventilator Free Days	Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.	Day 28

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Okawa Sumito	Rohto Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osaka University Hospital		Suita	Osaka	565-0871	Japan