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

NCT04659304 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-08-18

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DRUG

Allocetra-OTS

Cell-based therapy comprised of allogeneic non-HLA matched peripheral blood mononuclear cells induced to an early apoptotic state.

Sponsors & Collaborators

  • Enlivex Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Oren Hershkovitz, PhD · Enlivex Therapeutics R&D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-09-30
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659304 on ClinicalTrials.gov