NCT05947747

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Nano24med · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• ARDS

Interventions

Type	Name	Description
DRUG	EXO-CD24	Twice a day for 5 days, dose 10\^10
OTHER	Placebo	Twice a day for 5 days

Timeline

• Start date: 2023-07-04
• Primary completion: 2025-12-20
• Completion: 2025-12-20
• First posted: 2023-07-17
• Last updated: 2023-07-27

Locations

1 site across 1 country: Israel