Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection

SARS-CoV-2 Clinical Trial

Official title: A Phase I Feasibility Study to Evaluate the Safety of CD24-Exosomes in Patients With Moderate/Severe COVID-19 Infection

Status Recruiting

Clinical Trial Summary

This is an open-label Phase I study, four dose escalation groups, to evaluate the safety of CD24-exosomes in patients with moderate/severe COVID-19 disease.

Patients with moderate/severe COVID-19 infection and factors predictive of a cytokine storm are recruited from the Corona department of the Tel Aviv Sourasky Medical Center (TASMC), who have provided informed consent are being recruited in four dose groups who will receive the exosome treatment as an add-on treatment to standard treatment.

Clinical Trial Description

Coronavirus disease 2019 (COVID-19) is a highly transmissible disease in the community. The main cause of clinical deterioration that leads to death is the cytokine storm in the lung.

CD24 is a small heavily glycosylated GPI-anchored protein. CD24 is a key player in the vast majority of human cancers and also plays an important role in controlling the homeostatic proliferation of T cells. Hence, CD24 can negatively regulate inflammation.

The treatment is a biologic therapeutic agent based on exosomes carrying CD24. The rationale for this treatment is that exosomes overexpressing CD24, isolated and purified from T-REx™-293 cells engineered to express CD24 at high levels, can suppress the cytokine storm and are delivered directly to the target organ using exosomes as a highly body-compatible delivery vehicle. This enables a strong reduction of the required dose (as opposed to systemic administration), and reduces the risk for adverse events. ;

Related Conditions & MeSH terms

• Infection
• SARS-CoV-2

• NCT number: NCT04747574
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nadir Arber, Prof. MD MHA
• Phone: 972524266595
• Email: nadira@tlvmc.gov.il
• Status: Recruiting
• Phase: Phase 1
• Start date: September 25, 2020
• Completion date: March 25, 2021