Safety and Efficacy of EXO-CD24 in Preventing Clinical De... | NCT05947747

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

NCT05947747

Sponsor

Nano24med

Status

Unknown status

Last Update Posted

Jul 27, 2023Actual

Enrollment

90Estimated

Phase

Phase 2

Conditions

ARDS

Interventions

EXO-CD24
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2023Actual

Primary Completion Date

Dec 20, 2025Estimated

Completion Date

Dec 20, 2025Estimated

First Submitted Date

May 31, 2023

First Submission Date that Met QC Criteria

Jul 7, 2023

First Posted Date

Jul 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2023

Last Update Posted Date

Jul 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
EXO-CD24	Drug	Twice a day for 5 days, dose 10^10	Group 1: investigational drug EXO-CD24 at a dose of 10^10

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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.)
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nimrod Adi, MD	Contact	+972-524266719		nimroda@tlvmc.gov.il
Nadir Arber, Prof.	Contact	+972-524266595		nadira@tlvmc.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel-Aviv Sourasky Medical Center	Recruiting	Tel Aviv		64239	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided