Overview

A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS)

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2b multi-center, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of intravenous (IV) Allocetra-OTS 10x10^9 cells vs placebo (1:1) in adult hospitalized patients with severe or critical Coronavirus Disease 2019 (COVID-19) with associated acute respiratory distress syndrome (ARDS). Patients will be followed for efficacy and safety for 6 months. The trial will include periodic and ad-hoc DSMB review during the study period.
Phase:
Phase 2
Details
Lead Sponsor:
Enlivex Therapeutics Ltd.