A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection

NCT ID: NCT04969172

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-11
• Study Completion Date: 2022-07-11

Brief Summary

A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent.

155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.

Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.

Detailed Description

The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.

Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.

Study treatments will be given as add-on to standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. Patients who will be discharged before the end of the 5-day treatment period will continue to receive treatment at home. Treatment administration and the study assessments will be carried out by the research personnel at the home of the patient, implementing the required protective measures.

On Day 28, when the isolation period is completed, these patients will arrive at the study site for the follow-up visit.

Conditions

COVID-19 Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1010 Exosome

103 patients will receive either 1010 exosome particles.

Group Type: ACTIVE_COMPARATOR

Exosomes overexpressing CD24

Intervention Type: DRUG

The suggested therapeutic agent here is based on an existing therapeutic platform that uses exosomes that were engineered to overexpress CD24 that can directly suppress the cytokine storm. The exosomes will be isolated and purified from human embryonic kidney T-REx™-293 cells that constitutively express high levels of human CD24.

Placebo

52 patients will receive placebo- saline.

Group Type: PLACEBO_COMPARATOR

Exosomes overexpressing CD24

Intervention Type: DRUG

The suggested therapeutic agent here is based on an existing therapeutic platform that uses exosomes that were engineered to overexpress CD24 that can directly suppress the cytokine storm. The exosomes will be isolated and purified from human embryonic kidney T-REx™-293 cells that constitutively express high levels of human CD24.

Interventions

Exosomes overexpressing CD24

The suggested therapeutic agent here is based on an existing therapeutic platform that uses exosomes that were engineered to overexpress CD24 that can directly suppress the cytokine storm. The exosomes will be isolated and purified from human embryonic kidney T-REx™-293 cells that constitutively express high levels of human CD24.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test

2. Age 18-80 years

3. Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):

a. Clinical and Imaging-based evaluation i. Respiratory rate > 23/min and < 30/min ii. SpO2 at room air ≤94% and ≥90% iii. Bilateral pulmonary infiltrates >50% within 24-48 hours or a severe deterioration compared to imaging at admission b. Evidence of an exacerbated inflammatory process i. LDH score> 450 U/L ii. CRP >50 mg/L iii. Ferritin >1650 ng/ml iv. Lymphocytes >800 cells/mm3 v. D-dimers >1 mcg/ml

4. Willing and able to sign an informed consent

Exclusion Criteria

1. Age<18 years or >80 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. Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)

6. Unwilling or unable to provide informed consent

7. Participation in any other Interventional study in the last 30 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OBCTCD24 Ltd

UNKNOWN

Sponsor Role: collaborator

Eli Sprecher, MD

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eli Sprecher, MD

Dr. Guy Choshen

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

References

Pala M, Yilmaz SG. Circular RNAs, miRNAs, and Exosomes: Their Roles and Importance in Amyloid-Beta and Tau Pathologies in Alzheimer's Disease. Neural Plast. 2025 Apr 8;2025:9581369. doi: 10.1155/np/9581369. eCollection 2025.

Reference Type: DERIVED

PMID: 40235521 (View on PubMed)

Other Identifiers

0206-21-TLV

Identifier Type: -

Identifier Source: org_study_id