NCT05228899

Zofin to Treat COVID-19 Long Haulers

Completed Phase 1, PHASE2 Last updated 1 November 2023

What this trial tests

Phase 1, PHASE2 trial testing Zofin in COVID-19 in 18 participants. Completed in 18 October 2023.

Timeline

14 April 2022

Primary endpoint
1 October 2023

18 October 2023

Quick facts

Lead sponsor	ZEO ScientifiX, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	18
Start date	14 April 2022
Primary completion	1 October 2023
Estimated completion	18 October 2023
Sites	4 locations across United States

Drugs / interventions tested

• Zofin — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

ZEO ScientifiX, Inc. — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the safety and potential efficacy of Zofin administered intravenously in subjects experiencing prolonged symptoms (\> 6 weeks and \< 24 months) of COVID-19.

Publications & conference data

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

1. 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
2. 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
3. Clinical trials on the pharmacological treatment of long COVID: A systematic review.
   Chee YJ, Fan BE, Young BE, Dalan R, et al · · 2023 · cited 55× · PMID 36349400 · DOI 10.1002/jmv.28289
4. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
5. STIMULATE-ICP: A pragmatic, multi-centre, cluster randomised trial of an integrated care pathway with a nested, Phase III, open label, adaptive platform randomised drug trial in individuals with Long COVID: A structured protocol.
   Forshaw D, Wall EC, Prescott G, Dehbi HM, et al · · 2023 · cited 24× · PMID 36791116 · DOI 10.1371/journal.pone.0272472
6. Long COVID and possible preventive options.
   Sebők S, Gyires K. · · 2023 · cited 19× · PMID 37344737 · DOI 10.1007/s10787-023-01204-1
7. Harnessing exosomes for advanced osteoarthritis therapy.
   Selvadoss A, Baby HM, Zhang H, Bajpayee AG. · · 2024 · cited 14× · PMID 39323205 · DOI 10.1039/d4nr02792b
8. Immersed in a reservoir of potential: amniotic fluid-derived extracellular vesicles.
   Atukorala I, Hannan N, Hui L. · · 2024 · cited 13× · PMID 38609955 · DOI 10.1186/s12967-024-05154-2