Safety and Efficacy of EXO-CD24 in Preventing Clinical Deterioration in Patients With Mild-Moderate ARDS

NCT05947747 | Unknown Phase 2

• 1 other identifier: SN1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is phase IIb, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 of one dose 10\^10 exosome particles, to Prevent Clinical Deterioration in Patients with Mild-Moderate ARDS

Conditions

ARDS

Outcome Measures

Primary Outcomes (3)

• Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.

  28 days

• Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7

  7 days

• Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28

  28 days

Study Arms (2)

Group 1: investigational drug EXO-CD24 at a dose of 10^10

EXPERIMENTAL

60 patients who will receive a 5-day treatment with the investigational drug EXO-CD24 at a dose of 10\^10

Drug: EXO-CD24

Group 2: treatment in a clean sterile saline solution (placebo)

PLACEBO COMPARATOR

30 patients who will receive a 5-day treatment in a clean sterile saline solution (placebo)

Other: Placebo

Interventions

EXO-CD24 DRUG

Twice a day for 5 days, dose 10\^10

Also known as: Exosomes Overexpressing CD24

Group 1: investigational drug EXO-CD24 at a dose of 10^10

Placebo OTHER

Twice a day for 5 days

Group 2: treatment in a clean sterile saline solution (placebo)

Eligibility Criteria

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

You may qualify if:

• Direct and indirect lung injury etiology
• Age ≥18 years
• Patients with Early Acute Lung Injury (EALI) \> 2 ,or patient on HFNC/NIPPV \[(1 point for an oxygen requirement \> 2 to 6 liters/min or 2 points for \> 6 liters/min; 1 point each for a respiratory rate ≥ 30 breaths/min and baseline immune suppression) (immune system compromised by exogenous drug etc.)\] (For saturation goal \>90%) \[1\], or ARDS diagnosis (mild/moderate)
• Willing and able to sign an informed consent, or has a legal guardian who is able to sign

You may not qualify if:

• Any concomitant illness that, based on the judgment of the investigator might affect the interpretation or the results of the study (immunodeficiency, primary immune deficiency due to virus, hematological malignancy etc.)
• Patients with SaO2/FiO2\<150
• Patients with mechanical ventilation (ECMO).
• Pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding
• Participation in any other interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.

Sponsors & Collaborators

• Nano24med: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Central Study Contacts

Nimrod Adi, MD

CONTACT

+972-524266719; nimroda@tlvmc.gov.il

Nadir Arber, Prof.

CONTACT

+972-524266595; nadira@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The administrated dose will be unknown to the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two arms study; one arm will receive 10\^10 dose of exosomes overexpressing CD24, and the second arm will receive Placebo dose

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 17, 2023
• Study Start: July 4, 2023
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)