Clinical Trials for Nano24 (EXO-CD24)
Yes, clinical trials for Nano24 (EXO-CD24) have been completed and published, demonstrating safety and preliminary efficacy in COVID-19-related ARDS, though no large-scale randomized controlled trials are currently registered or ongoing.
Available Clinical Evidence
The published clinical experience with EXO-CD24 includes:
Phase IIb Randomized Trial
A randomized, single-blind, dose-finding phase IIb trial enrolled 91 patients with mild-to-moderate COVID-19-related ARDS across two medical centers in Athens 1. Patients received either 10⁹ or 10¹⁰ exosome particles daily via inhalation for five consecutive days with 28-day monitoring. By day 7,83.7% showed improved respiratory signs and 64% had better oxygen saturation, with significant reductions in inflammatory markers including CRP, LDH, ferritin, and fibrinogen 1. No treatment-related adverse events occurred, and only 2 patients died 1.
Phase Ib/IIa Safety Study
An earlier phase Ib/IIa study recruited 35 patients with moderate-to-high severity COVID-19 who received escalating doses (10⁸ to 10¹⁰ particles) of EXO-CD24 by inhalation once daily for 5 days 2. No adverse events related to the drug were observed during follow-up extending 443-575 days 2. The treatment effectively reduced inflammatory markers and cytokine/chemokine levels 2.
Compassionate Use Experience
Eleven critically ill, intubated patients with severe ARDS (10 COVID-19,1 adenovirus) received EXO-CD24 across four Israeli medical centers 3. The overall mortality rate was 36%, with notably lower mortality (12.5%) at Tel Aviv Medical Center 3. No adverse events were recorded, and cytokine/chemokine production was significantly suppressed in all patients 3.
Current Trial Status
No ongoing large-scale randomized controlled trials are currently registered in major trial databases for EXO-CD24/Nano24. The published studies represent early-phase clinical experience totaling over 180 ARDS patients 4, but these were primarily safety and preliminary efficacy assessments rather than definitive phase III trials.
Important Caveats
- The phase IIb trial was single-blind rather than double-blind, introducing potential bias
- Post-hoc comparisons with observational control groups (n=202) showed favorable results 1, but these were not pre-specified randomized comparisons
- All published trials focused exclusively on COVID-19-related or post-infection ARDS, not other pulmonary conditions
- The drug label information 5 appears to reference a different product (hand sanitizer), not the therapeutic EXO-CD24 formulation
Clinical Implications
For patients with severe ARDS and limited treatment options, EXO-CD24 demonstrated a favorable safety profile across >180 patients with no treatment-related adverse events 1, 3, 2. However, definitive efficacy data from adequately powered, randomized, placebo-controlled trials are lacking. The mechanism—CD24 binding DAMPs to inhibit NF-κB pathway activation without interfering with pathogen clearance 2, 4—is biologically plausible but requires validation in rigorous trials.
The authors of the phase IIb study explicitly state that "further investigation in a larger, international, randomized, quadri-blind trial against a placebo" is warranted 1.