NCT04969172

A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection

Status unknown Phase 2 Last updated 20 July 2021

What this trial tests

Phase 2 trial testing Exosomes overexpressing CD24 in COVID-19 Disease in 155 participants. Status unknown.

Timeline

11 July 2021

Primary endpoint
11 July 2022

11 July 2022

Quick facts

Lead sponsor	Eli Sprecher, MD
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	155
Start date	11 July 2021
Primary completion	11 July 2022
Estimated completion	11 July 2022
Sites	1 location across Israel

Drugs / interventions tested

• Exosomes overexpressing CD24 — full drug profile →

Conditions studied

• COVID-19 Disease — all drugs for COVID-19 Disease →

Sponsor

Eli Sprecher, MD — full company profile →

Who can join

Adults 18 to 80, any sex, with COVID-19 Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent.

155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.

Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The roles of extracellular vesicles in the immune system.
   Buzas EI. · · 2023 · cited 811× · PMID 35927511 · DOI 10.1038/s41577-022-00763-8
2. Clinical applications of stem cell-derived exosomes.
   Tan F, Li X, Wang Z, Li J, et al · · 2024 · cited 390× · PMID 38212307 · DOI 10.1038/s41392-023-01704-0
3. Nanotechnology's frontier in combatting infectious and inflammatory diseases: prevention and treatment.
   Huang Y, Guo X, Wu Y, Chen X, et al · · 2024 · cited 188× · PMID 38378653 · DOI 10.1038/s41392-024-01745-z
4. Emerging phagocytosis checkpoints in cancer immunotherapy.
   Liu Y, Liu Y, Wang Y, Yang Y, et al · · 2023 · cited 186× · PMID 36882399 · DOI 10.1038/s41392-023-01365-z
5. Development of Extracellular Vesicle Therapeutics: Challenges, Considerations, and Opportunities.
   Claridge B, Lozano J, Poh QH, Greening DW. · · 2021 · cited 132× · PMID 34616741 · DOI 10.3389/fcell.2021.734720
6. Biological Features of Extracellular Vesicles and Challenges.
   Zeng Y, Qiu Y, Jiang W, Shen J, et al · · 2022 · cited 95× · PMID 35813192 · DOI 10.3389/fcell.2022.816698
7. Advances in the use of exosomes for the treatment of ALI/ARDS.
   Liu C, Xiao K, Xie L. · · 2022 · cited 61× · PMID 36016948 · DOI 10.3389/fimmu.2022.971189
8. Engineering therapeutical extracellular vesicles for clinical translation.
   Ma Y, Dong S, Grippin AJ, Teng L, et al · · 2025 · cited 58× · PMID 39227240 · DOI 10.1016/j.tibtech.2024.08.007