ARDSPhase 2NCT05947747
Safety and Efficacy of EXO-CD24 in Preventing Clinical Deterioration in Patients With Mild-Moderate ARDS
A Phase 2 study testing EXO-CD24 in people with ARDS, run by Nano24med at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- EXO-CD24
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Jul 2023to 20 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Nadir Arber, Professor, +972-524266595, nadira@tlv.mc.gov.il
Nimrod Adi, MD, +972-524266719, nimroda@tlvmc.gov.il
About this study
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
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
Read the 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
- Being tested
- EXO-CD24, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXO-CD24Drug
Also called Exosomes Overexpressing CD24
Twice a day for 5 days, dose 10^10
PlaceboOther
Twice a day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.
Measured: 28 days
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7
Measured: 7 days
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start4 Jul 2023
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nano24med
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947747
- Sponsor's protocol ID
- SN1
- Status last verified
- Jul 2023
- First submitted
- 31 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05947747
- Acronym / sponsor ID
- SN1
- Conditions
- ARDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nano24medUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1: investigational drug EXO-CD24 at a dose of 10^10 | Experimental | Drug: EXO-CD2460 patients who will receive a 5-day treatment with the investigational drug EXO-CD24 at a dose of 10^10 |
| Group 2: treatment in a clean sterile saline solution (placebo) | Placebo comparator | Other: Placebo30 patients who will receive a 5-day treatment in a clean sterile saline solution (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXO-CD24Also: Exosomes Overexpressing CD24Twice a day for 5 days, dose 10^10 | Drug | Group 1: investigational drug EXO-CD24 at a dose of 10^10 |
| PlaceboTwice a day for 5 days | Other | Group 2: treatment in a clean sterile saline solution (placebo) |
Primary outcome
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
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7
Time frame: 7 days
Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EXO-CD24 in people with ARDS, run by Nano24med at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimrod Adi, MD (+972-524266719, nimroda@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.