Last reviewed · How we verify
NCT05125562
Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19
Withdrawn
Phase 2
Last updated 13 February 2024
What this trial tests
Phase 2 trial testing ExoFlo in COVID-19. Withdrawn.
Timeline
7 December 2022
Primary endpoint
7 March 2023
7 March 2023
7 March 2023
Quick facts
| Lead sponsor | Direct Biologics, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 7 December 2022 |
| Primary completion | 7 March 2023 |
| Estimated completion | 7 March 2023 |
Drugs / interventions tested
- ExoFlo — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Direct Biologics, LLC — full company profile →
Who can join
Adults 18 to 85, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Early Mild Outpatient infusion Therapy with ExoFloTM for COVID-19 (EMOTE COVID-19) To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for mild-moderate COVID-19.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The roles of extracellular vesicles in the immune system.
Buzas EI. · · 2023 · cited 811× · PMID 35927511 · DOI 10.1038/s41577-022-00763-8 -
Mesenchymal stem cell-derived extracellular vesicles for immunomodulation and regeneration: a next generation therapeutic tool?
Kou M, Huang L, Yang J, Chiang Z, et al · · 2022 · cited 382× · PMID 35787632 · DOI 10.1038/s41419-022-05034-x -
Exosomes─Nature's Lipid Nanoparticles, a Rising Star in Drug Delivery and Diagnostics.
Tenchov R, Sasso JM, Wang X, Liaw WS, et al · · 2022 · cited 336× · PMID 36354238 · DOI 10.1021/acsnano.2c08774 -
Mesenchymal stem cell secretome for regenerative medicine: Where do we stand?
Trigo CM, Rodrigues JS, Camões SP, Solá S, et al · · 2025 · cited 82× · PMID 38729561 · DOI 10.1016/j.jare.2024.05.004 -
Extracellular Vesicles as Therapeutic Resources in the Clinical Environment.
Sanz-Ros J, Mas-Bargues C, Romero-García N, Huete-Acevedo J, et al · · 2023 · cited 53× · PMID 36768664 · DOI 10.3390/ijms24032344 -
Understanding molecular characteristics of extracellular vesicles derived from different types of mesenchymal stem cells for therapeutic translation.
Ding Z, Greenberg ZF, Serafim MF, Ali S, et al · · 2024 · cited 34× · PMID 38957857 · DOI 10.1016/j.vesic.2024.100034 -
Mesenchymal Stem Cell-Derived Extracellular Vesicles for Therapeutic Use and in Bioengineering Applications.
McLaughlin C, Datta P, Singh YP, Lo A, et al · · 2022 · cited 32× · PMID 36359762 · DOI 10.3390/cells11213366 -
Mechanisms and clinical application potential of mesenchymal stem cells-derived extracellular vesicles in periodontal regeneration.
Chen L, Zhu S, Guo S, Tian W. · · 2023 · cited 30× · PMID 36782259 · DOI 10.1186/s13287-023-03242-6
Verify or expand the search:
- PubMed search for NCT05125562
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ExoFlo
Trials testing the same drug.
- NCT05836883 — Study of ExoFlo for the Treatment of Perianal Fistulas · Phase 1, PHASE2 · terminated
- NCT05130983 — Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease · Phase 1 · terminated
- NCT05176366 — Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis · Phase 1 · terminated
- NCT05354141 — Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS) · Phase 3 · recruiting
- NCT04493242 — Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS · Phase 2 · completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
- NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Direct Biologics, LLC trials
Trials by the same sponsor.
- NCT06918808 — DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease · Phase 2 · recruiting
- NCT05836883 — Study of ExoFlo for the Treatment of Perianal Fistulas · Phase 1, PHASE2 · terminated
- NCT05130983 — Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease · Phase 1 · terminated
- NCT05176366 — Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis · Phase 1 · terminated
- NCT05354141 — Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS) · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05125562 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Direct Biologics, LLC
- Last refreshed: 13 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05125562.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing