Table 4.
Summary of ongoing NCT registered clinical trials of extracellular vesicle-based therapies for COVID-19 (updated on January 28, 2024).
| NCT number | Title | Study Design | Specification of the biological product | Number of patients | Phase/Status | Location |
|---|---|---|---|---|---|---|
| NCT04493242 | Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS (EXIT-COVID19) | Randomized placebo-controlled | Intravenous administration of bone marrow mesenchymal stem cell-derived extracellular vesicles | 102 | Phase II - Completed | USA |
| NCT05787288 | A Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cell Exosomes for the Treatment of COVID-19. | Randomized | Extracellular Vesicles from Mesenchymal Stem Cells from umbilical cord blood | 240 | Early phase I - recruiting | China |
| NCT04657458 | Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS | Expanded Access | ExoFlo: Intravenous administration of bone marrow mesenchymal stem cell-derived extracellular vesicles | Intermediate-size population | Phase II/Expanded Access | Not provided |
| NCT05808400 | Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19 | Non-randomized | MSC-derived exosomes | 80 | Early Phase I - Recruiting | China |
| 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 | Randomized, Double-blind, Placebo-controlled | Exosomes overexpressing CD24 | 155 | Phase II - Unknown | Israel |
| NCT05216562 | Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients (EXOMSC-COV19) | Randomized, double-blind clinical trial. | Exosome-MSC Intravenous injection | 60 | Phase II/Phase III – Recruiting | Indonesia |
| NCT04902183 | Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients with Moderate or Severe COVID-19 | Randomized | Exosomes overexpressing CD24 | 90 | Phase II -Unknown | Greece |
| NCT04602442 | Safety and Efficiency of Method of Exosome Inhalation in COVID-19 Associated Pneumonia (COVID-19EXO2) | Randomized | Aerosol inhalation of the exosomes | 90 | Phase II -Unknown | Russian Federation |
| NCT05191381 | Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19 | Observational | Application of exosomes in a whole blood assay | 40 | NA | Germany |
| NCT04389385 | Aerosol Inhalation of the Exosomes Derived from Allogenic COVID-19 T Cell in the Treatment of Early Stage Novel Coronavirus Pneumonia | Single arm | COVID-19 Specific T Cell derived exosomes (CSTC-Exo) | 60 | Phase I - Unknown | Turkey |
| NCT05387278 | Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated with the novel Corona Virus Infection (COVID-19) | Randomized placebo controlled | EV-Pure™ and WJ-Pure™ | 20 | Phase 1 – Recruiting | USA |
| NCT04491240 | Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia. (COVID-19EXO) | Randomized placebo controlled | aerosol inhalation of the exosomes | 30 | Phase I/Phase II | Russian Federation |
| NCT05116761 | ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome | Randomized placebo controlled | Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles | 60 | Phase I/II | Not provided |