Using exosomes to prevent worsening in patients with mild to moderate ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IIb clinical trial evaluates the safety and efficacy of EXO-CD24, a treatment involving exosomes overexpressing CD24, in preventing clinical deterioration in patients diagnosed with mild to moderate Acute Respiratory Distress Syndrome (ARDS). The study will enroll 90 patients who will be randomized in a 2:1 ratio to receive either the treatment or a placebo, with the treatment administered via a nebulizer twice daily for five days. Patients will be monitored for an additional 23 days post-treatment to assess outcomes and safety. The study aims to provide insights into the potential of exosome therapy in managing ARDS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Direct and indirect lung injury etiology
2. Age ≥18 years
3. 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)
4. Willing and able to sign an informed consent, or has a legal guardian who is able to sign

Exclusion Criteria:

1. 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.)
2. Patients with SaO2/FiO2\<150
3. Patients with mechanical ventilation (ECMO).
4. Pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding
5. Participation in any other interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.

Where it's running

• Tel-Aviv Sourasky Medical Center
  Tel-Aviv, Israel Recruiting

Study contacts

• Study coordinator: Nimrod Adi, MD
• Email: nimroda@tlvmc.gov.il
• Phone: +972-524266719

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fibrinogen-to-Albumin Ratio as a Predictor of ARDS in Traumatic Brain Injury

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• Gastric versus postpyloric feeding for adults with ARDS on prone ventilation

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• Using higher PEEP with mask noninvasive ventilation for people with pneumonia or ARDS

  This trial will test whether giving higher PEEP through a mask during noninvasive ventilation helps adults with pneumonia or ARDS avoid intubation and improve oxygenation.

  Recruiting Chongqing Medical University · Chongqing · NCT07298889

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.