A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Community Acquired Pneumonia
- Organ Dysfunction Syndrome
- Sepsis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Up to 160 patients will be allocated in a 1:1:1:1 ratio between the 4 cohorts : Placebo Single Intravenous (IV) dose of Allocetra-OTS, 5x109 cells Single IV dose of Allocetra-OTS, 10x109 cells Single or two IV doses of Allocetra-OTS, 10x109 cells in each doseMasking: Double (Participant, Investigator)Masking Description: Randomization will be in a double blinding fashion which will be kept until study Day 4 followed by a single blinding until the end of the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 85 years
- Gender
- Both males and females
Description
Up to 160 eligible patients will be allocated in a 1:1:1:1 ratio between the 4 cohorts (up to 40 patients in each cohort). Randomization will be in a double blinding fashion which will be kept until Day 4 followed by a single blinding until the end of the study. Randomization will be stratified by s...
Up to 160 eligible patients will be allocated in a 1:1:1:1 ratio between the 4 cohorts (up to 40 patients in each cohort). Randomization will be in a double blinding fashion which will be kept until Day 4 followed by a single blinding until the end of the study. Randomization will be stratified by screening Sequential Organ Failure Assessment (SOFA) score (2-6 vs. 7-9). Patients will be followed over 28 days for efficacy and continue safety follow up of 12 months from IP administration. Patients participating in this study, regardless if hospitalized or discharged, will be followed daily through Day 7 (inclusive, short-term follow-up), then on Days 10 (only for patients receiving 2nd dose), Day 14, and Day 28 (medium-term follow-up), , and then at 3 months, 6 months and 12 months (long-term safety follow-up).
Tracking Information
- NCT #
- NCT04612413
- Collaborators
- Cato Research
- Investigators
- Principal Investigator: Pierre Singer, MD Rabin medical center, Belinson Campus, Petah Tiqwa Isarel
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