An Exploratory Study of ADR-001 in Patients with Severe Pneumonia caused by SARS-CoV-2 infection (COVID-19)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225320

Enrollment

Registered

2020-08-19

Start date

2020-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Severe Pneumonia caused by SARS-CoV-2 infection

Interventions

investigational material(s) Generic name etc : Adipose-Derived Mesenchymal Stem Cell INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational mate

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
safety Adverse Event	—

Secondary

Measure	Time frame
efficacy 1) 28-day mortality rate 2) Duration of mechanical ventilation use 3) Duration of ICU stay 4) Lung opacity score on chest X-ray 5) PaO2 / FiO2 ratio 6) Oxygen index 7) Body temperature 8) White blood cell quantity 9) CRP 10) LDH 11) Degree of damage to important organs in SOFA score 12) Cytokine quantity (IL-2, IL-6, IL-8, IL-10, TNF-alpha, IFN-gamma) 13) ECOG PS score 14) 7 category ordinal scale 15) NEWS 2	—

Measure

Time frame

efficacy 1) 28-day mortality rate 2) Duration of mechanical ventilation use 3) Duration of ICU stay 4) Lung opacity score on chest X-ray 5) PaO2 / FiO2 ratio 6) Oxygen index 7) Body temperature 8) White blood cell quantity 9) CRP 10) LDH 11) Degree of damage to important organs in SOFA score 12) Cytokine quantity (IL-2, IL-6, IL-8, IL-10, TNF-alpha, IFN-gamma) 13) ECOG PS score 14) 7 category ordinal scale 15) NEWS 2

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026