jRCT2043210005CompletedNot Applicable
Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection (Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Life Science Institute, Inc.
- Enrollment
- 43
- Primary Endpoint
- Safety
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
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
Outcomes
Primary Outcomes
Safety
incidence of Adverse events (AEs), adverse drug reactions (ADRs)
Efficacy
Time Frame: 4 weeks after administration
mortality up to 4 weeks after administration
Secondary Outcomes
No secondary outcomes reported
Investigators
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