A Phase 2 Study of ADR-001 in Patients with Severe Pneumonia caused by SARS-CoV-2 infectio
Phase 2
Recruiting
- Conditions
- Patients with Severe Pneumonia caused by SARS-CoV-2 infection
- Registration Number
- JPRN-jRCT2053210023
- Lead Sponsor
- Okawa Sumito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
SARS-CoV-2 infection is confirmed on antigen test or PCR test
-Pulmonary infiltrative shadow is confirmed on chest X-ray test
-Just after mechanical ventilation support start (equal to it would be possible to administer an Investigational Product to a subject within 72h from the mechanical ventilation support start)
-PaO2/FiO2 <=200mmHg at the time of screening
Exclusion Criteria
-Continue 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 Ventilator Free Days (Time Frame: Day 28)
- Secondary Outcome Measures
Name Time Method 1) Mortality rate(Day 28 and Day 85)<br>2) Duration of ICU stay(Time Frame: Day 28)<br>3) Change in Lung opacity score on chest X-ray<br>4) Change in PaO2/FiO2 <br>5) Change in SpO2/FiO2 <br>6) Change in Oxygen index<br>7) Change in PEEP<br>8) Number of days to meet criteria of spontaneous breathing trials by Day29<br>9) Change in CRP<br>10) Change in LDH<br>11) Change in SOFA score<br>12) Change in Cytokine quantity(IL-6, IL-10, TNF-alpha, KL-6, TARC)<br>13) Number of days to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category ordinal Scale of Clinical Status by Day 29<br>14) Number of days Time to Improvement of at Least 3 Categories Relative to Baseline on a 7-Category ordinal Scale of Clinical Status by Day 29<br>15) Change in 7 category ordinal scale<br>16) Change in NEWS2<br>17) Adverse event