Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infectio
Phase 1
- Conditions
- acute respiratory distress syndrome
- Registration Number
- JPRN-jRCT2043210005
- Lead Sponsor
- Fukushima Tatsunobu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
SARS-CoV-2 positive patients by RT-PCR
-Patients diagnosed with ARDS by Berlin definition
-Patients who are intubated and under mechanical ventilatory control
Exclusion Criteria
-Patients managed by Extracorporeal Membrane Oxygenation (ECMO) or using ventilation techniques such as High Frequency Oscillatory Ventilation (HFOV)
-Patients who are not expected to survive for about 72 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method STEP 1 : Safety as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs)<br>STEP 2 : Efficacy as measured by mortality up to 4 weeks after administration
- Secondary Outcome Measures
Name Time Method