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

NCT ID: NCT04747574

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2021-03-25

Brief 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.

Detailed 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.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXO-CD24 exosome treatment

Group 1, 5 patients are treated with 1x10^8 exosome particles per 2 ml saline.

Group 2: 5 patients are treated with 5x10^8 exosome particles per 2 ml saline.

Group 3: 20 patients are treated with 1x10^9 exosomes particles per 2 ml saline.

Group 4: 5 patients are treated with 1x10^10 exosomes particles per 2 ml saline.

The drug is aerosolized in normal saline for inhalation and administered via a standard hospital-grade inhalation device, QD for 5 days. Study treatment is given as an add-on to the standard of care.

Group Type: OTHER

EXO-CD24

Intervention Type: DRUG

The study active treatment is EXO-CD24 -exosomes (natural nano-sized vesicles secreted by human cells) that were engineered to overexpress CD24, aerosolized in normal saline for inhalation via a standard hospital-grade inhalation device, QD for 5 days.

Interventions

EXO-CD24

The study active treatment is EXO-CD24 -exosomes (natural nano-sized vesicles secreted by human cells) that were engineered to overexpress CD24, aerosolized in normal saline for inhalation via a standard hospital-grade inhalation device, QD for 5 days.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. Age<18 years or >85 years

2. Any concomitant illness that, based on the judgment of the Investigator is terminal

3. Ventilated patient

4. Pregnancy (positive urine pregnancy test [women of childbearing potential only]) or breastfeeding

5. Unwilling or unable to provide informed consent

6. Participation in any other study in the last 30 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eli Sprecher, MD

Nadir Arber MD, MSc, MHA Professor of Medicine and Gastroenterology. Head of the Health Promotion Center and the Integrated Cancer Prevention Center Tel-Aviv Sourasky Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadir Arber, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Nadir Arber, Prof. MD MHA

Role: CONTACT

nadira@tlvmc.gov.il

972524266595 ext. 0

Facility Contacts

Nadir Arber, Prof.

Role: primary

nadira@tlvmc.gov.il

Other Identifiers

0254-20-TLV

Identifier Type: -

Identifier Source: org_study_id