drugset / Trial / NCT04659304

Study Evaluating Safety and Tolerability of Allocetra-OTS in Patients With COVID-19

NCT04659304

Phase 1 Unknown 18 enrolled Enlivex Therapeutics Ltd.
RandomizedSequentialOpen-labelTreatment

Summary

Phase 1b, multi-center, open label, sequential dose escalation trial assessing 3 dose cohorts using a 3+3 design to evaluate safety and tolerability of Allocetra-OTS in adult patients with moderate COVID-19. The sample size for this trial is anticipated to range from 9 to 18 patients.

Timeline

Start
2021-12
Primary completion
2022-09
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Allocetra-OTS Cell therapy 5e+09 cells Intravenous
Comparator Allocetra-OTS Cell therapy 1e+10 cells Intravenous

Indications