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

NCT04969172 | Unknown Phase 2 DMC

• 1 other identifier: 0206-21-TLV
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Disease

Keywords

AE- Adverse event; BUN - Blood urea nitrogen; CI- Confidence Interval; CMP - Clinical monitoring plan; CONSORT- Consolidated Standards of Reporting Trials; CRF - Case Report Form; DAMP- Damage-associated molecular patterns; DMEM- Dulbecco's Modified Eagle's Medium; GCP - Good Clinical Practice; GMP- Good Manufacturing Practice; GVHD- Graft-versus-host disease; HCT - Hematopoietic stem cell transplantation; ICH- International Conference on Harmonization; IDSA- Infectious Diseases Society of America; IRB- Institutional Review Board; ITT- Intend-to-Treat analysis set; mITT- Modified Intent-to-Treat analysis set; NLR - Neutrophil-to-lymphocyte ratio; PCR - Polymerase chain reaction; PI- Principal Investigator; PP- Per-Protocol analysis set; SA- Safety analysis set; SAE- Serious adverse event; SoA- Schedule of Activities; TLR- Toll-like receptors

Outcome Measures

Primary Outcomes (7)

• To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease

  One year

• To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease

  One year

• To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.

  One year

• To evaluate the death rate.

  One year

• To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).

  One year

• To evaluate time from hospitalization to hospital discharge.

  One year

• To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.

  One year

Secondary Outcomes (4)

• To evaluate the effect of EXO-CD24 on the respiratory rate.

  One year

• To evaluate the effect of EXO-CD24 on the change in blood oxygen saturation (SpO2).

  One year

• To evaluate the effect of EXO-CD24 on the proportion of patients requiring ventilation.

  One year

• To evaluate the effect of EXO-CD24 on the level of inflammatory markers (eg, CRP, ferritin, fibrinogen, di-dimers, IL-6, LDH, lymphocytes count.

  One year

Study Arms (2)

1010 Exosome

ACTIVE COMPARATOR

103 patients will receive either 1010 exosome particles.

Drug: Exosomes overexpressing CD24

Placebo

PLACEBO COMPARATOR

52 patients will receive placebo- saline.

Drug: Exosomes overexpressing CD24

Interventions

Exosomes overexpressing CD24 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.

1010 Exosome; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
• Age 18-80 years
• 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
• Willing and able to sign an informed consent

You may not qualify if:

• Age\<18 years or \>80 years
• Any concomitant illness that, based on the judgment of the Investigator is terminal
• Ventilated patient
• Pregnancy (positive urine pregnancy test \[women of childbearing potential only\]) or breastfeeding
• Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)
• Unwilling or unable to provide informed consent
• Participation in any other Interventional study in the last 30 days

Sponsors & Collaborators

• Eli Sprecher, MD: lead
• OBCTCD24 Ltd: collaborator

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

• 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.

  PMID: 40235521 DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles -103 patients, or placebo- 52 patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Guy Choshen

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 20, 2021
• Study Start: July 11, 2021
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)