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

Sponsor

Nano24med (Other)

Overall Status

Recruiting

CT.gov ID

NCT05947747

Collaborator

(none)

Enrollment

Location

Arms

29.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
ARDS	Drug: EXO-CD24 Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

The administrated dose will be unknown to the patients

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 4, 2023

Anticipated Primary Completion Date :

Dec 20, 2025

Anticipated Study Completion Date :

Dec 20, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study. [One year]
Efficacy: To evaluate the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7 and day 28 [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Direct and indirect lung injury etiology
Age ≥18 years
Patients with Early Acute Lung Injury (EALI) > 2 [(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

Exclusion Criteria:

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. baseline immune suppression- immune system compromised by exogenous drug etc.)
Patients with SaO2/FiO2<150
Patients with mechanical ventilation (ECMO), or NIV, or high flow nasal cannula.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel-Aviv Sourasky Medical Center	Tel-Aviv		Israel	64239

Sponsors and Collaborators

Nano24med

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nano24med

ClinicalTrials.gov Identifier:

NCT05947747

Other Study ID Numbers:

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Clinical Deterioration

Study Results

No Results Posted as of Jul 17, 2023