UnknownPhase 2

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

Israel90 participantsStarted 2023-07-04

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.

Timeframe: 28 days

Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7

Timeframe: 7 days

Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28

Timeframe: 28 days

Trial details

NCT IDNCT05947747

SponsorNano24med

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-20

Contact for this trial

Nimrod Adi, MD

+972-524266719 nimroda@tlvmc.gov.il

View on ClinicalTrials.gov More ARDS trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v.5 during the 28 days of the study.

Timeframe: 28 days

Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 7

Timeframe: 7 days

Efficacy: the rate of hypoxemic respiratory failure (reported as S/F<150) at day 28

Timeframe: 28 days