An Exploratory Study of ADR-001 in Patients with Severe Pneumonia caused by SARS-CoV-2 infection (COVID-19)
Phase 1
Completed
- Conditions
- Patients with Severe Pneumonia caused by SARS-CoV-2 infection
- Registration Number
- JPRN-jRCT1080225320
- Lead Sponsor
- ROHTO PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse Event
- Secondary Outcome Measures
Name Time Method efficacy<br>1) 28-day mortality rate<br>2) Duration of mechanical ventilation use<br>3) Duration of ICU stay<br>4) Lung opacity score on chest X-ray<br>5) PaO2 / FiO2 ratio<br>6) Oxygen index<br>7) Body temperature<br>8) White blood cell quantity<br>9) CRP<br>10) LDH<br>11) Degree of damage to important organs in SOFA score<br>12) Cytokine quantity (IL-2, IL-6, IL-8, IL-10, TNF-alpha, IFN-gamma)<br>13) ECOG PS score<br>14) 7 category ordinal scale<br>15) NEWS 2