NCT04888949

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
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2021

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

May 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

May 9, 2021

Last Update Submit

November 17, 2023

Conditions

SARS-CoV-2 Infection( COVID-19 )

Outcome Measures

Primary Outcomes (1)

  • Ventilator Free Days

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

    Day 28

Study Arms (2)

Mesenchymal stem cell

EXPERIMENTAL

4 times dose of Mesenchymal stem cell

Biological: Mesenchymal stem cell

Placebo

PLACEBO COMPARATOR

Saline

Biological: Placebo

Interventions

Mesenchymal stem cellBIOLOGICAL

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

Mesenchymal stem cell
PlaceboBIOLOGICAL

Commercially available saline.

Placebo

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
  • PaO2/FiO2 \<=200mmHg at the time of screening

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

  • Okawa Sumito

    Rohto Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 17, 2021

Study Start

June 15, 2021

Primary Completion

May 18, 2023

Study Completion

May 18, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

JP(1)