Back to resultsSafety and Efficacy of EXO-CD24 in Preventing Clinical Deterioration in Patients With Mild-Moderate ARDS
Primary Purpose
ARDS
Status
Recruiting
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
EXO-CD24
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for ARDS
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.
Sites / Locations
- Tel-Aviv Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1: investigational drug EXO-CD24 at a dose of 10^10
Group 2: treatment in a clean sterile saline solution (placebo)
Arm Description
60 patients who will receive a 5-day treatment with the investigational drug EXO-CD24 at a dose of 10^10
30 patients who will receive a 5-day treatment in a clean sterile saline solution (placebo)
Outcomes
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.
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05947747
Brief Title
Safety and Efficacy of EXO-CD24 in Preventing Clinical Deterioration in Patients With Mild-Moderate ARDS
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2023 (Actual)
Primary Completion Date
December 20, 2025 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nano24med
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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 dose
Masking
Participant
Masking Description
The administrated dose will be unknown to the patients
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: investigational drug EXO-CD24 at a dose of 10^10
Arm Type
Experimental
Arm Description
60 patients who will receive a 5-day treatment with the investigational drug EXO-CD24 at a dose of 10^10
Arm Title
Group 2: treatment in a clean sterile saline solution (placebo)
Arm Type
Placebo Comparator
Arm Description
30 patients who will receive a 5-day treatment in a clean sterile saline solution (placebo)
Intervention Type
Drug
Intervention Name(s)
EXO-CD24
Other Intervention Name(s)
Exosomes Overexpressing CD24
Intervention Description
Twice a day for 5 days, dose 10^10
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Twice a day for 5 days
Primary Outcome Measure Information:
Title
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.
Time Frame
28 days
Title
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7
Time Frame
7 days
Title
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nimrod Adi, MD
Phone
+972-524266719
Email
nimroda@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Nadir Arber, Prof.
Phone
+972-524266595
Email
nadira@tlvmc.gov.il
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadir Arber, Professor
Phone
+972-524266595
Email
nadira@tlv.mc.gov.il
First Name & Middle Initial & Last Name & Degree
Nimrod Adi, MD
Phone
+972-524266719
Email
nimroda@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Nimrod Adi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of EXO-CD24 in Preventing Clinical Deterioration in Patients With Mild-Moderate ARDS
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