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

A Phase IIb, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Mild-Moderate ARDS

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

Study Overview

• Status: Recruiting
• Conditions: ARDS
• Intervention / Treatment: Drug: EXO-CD24; Other: Placebo

Detailed Description

The study population will include patients with mild-moderate ARDS and laboratory markers predictive of the cytokine storm, who have provided an informed consent.

90 patients will be initially screened, randomized and stratified by center in a 2:1 ratio to receive either 1010 exosome particles (60 patients) or placebo (30 patients).

Study drug will be delivered using standard jet nebulizer that produce aerosol particles size of 0.4-4.4 µm.

The exosomes will be diluted in 1.5 ml normal saline for inhalation, administered twice a day (bid) for 5 days

Study treatments will be given as an add-on to the standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. In case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nimrod Adi, MD; Phone Number: +972-524266719; Email: nimroda@tlvmc.gov.il
• Study Contact Backup: Name: Nadir Arber, Prof.; Phone Number: +972-524266595; Email: nadira@tlvmc.gov.il

Study Locations

• Israel
  • Tel-Aviv, Israel, 64239
    • Recruiting
    • Tel-Aviv Sourasky Medical Center
    • Contact: Nimrod Adi, MD; Phone Number: +972-524266719; Email: nimroda@tlvmc.gov.il
    • Contact: Nadir Arber, Professor; Phone Number: +972-524266595; Email: nadira@tlv.mc.gov.il
    • Principal Investigator: Nimrod Adi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Direct and indirect lung injury etiology
2. Age ≥18 years
3. 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)
4. Willing and able to sign an informed consent, or has a legal guardian who is able to sign

Exclusion Criteria:

1. 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.)
2. Patients with SaO2/FiO2<150
3. Patients with mechanical ventilation (ECMO).
4. Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding
5. Participation in any other interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: investigational drug EXO-CD24 at a dose of 10^10; 60 patients who will receive a 5-day treatment with the investigational drug EXO-CD24 at a dose of 10^10	Drug: EXO-CD24; Twice a day for 5 days, dose 10^10; Other Names: Exosomes Overexpressing CD24
Placebo Comparator: Group 2: treatment in a clean sterile saline solution (placebo); 30 patients who will receive a 5-day treatment in a clean sterile saline solution (placebo)	Other: Placebo; Twice a day for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nano24med

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: SN1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No