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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947747
• Other study ID #: SN1
• Status: Recruiting
• Phase: Phase 2
• Start date: July 4, 2023
• Est. completion date: December 20, 2025

Study information

• Verified date: July 2023
• Source: Nano24med
• Contact: Nimrod Adi, MD
• Phone: +972-524266719
• Email: nimroda[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 20, 2025
• Est. primary completion date: December 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• Clinical Deterioration

Intervention

Drug:
• EXO-CD24
Twice a day for 5 days, dose 10^10

Other:
• Placebo
Twice a day for 5 days

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Nano24med

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.		28 days
Primary	Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7		7 days
Primary	Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28		28 days