NCT05228899

Zofin to Treat COVID-19 Long Haulers

A Phase I/II Multicenter, Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Zofin Infused Intravenous (IV) in Patients Experiencing Prolonged COVID-19 Symptoms (Long-Haulers) vs Placebo.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: ZEO ScientifiX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a phase I/II randomized, double blinded and placebo control. COVID-19 Long Haulers In double blinded and placebo control trial, neither the patients nor the researchers know who is getting a placebo and who is getting the treatment. The ratio between groups is 1:1 for total 30 subjects. Each subject will be randomized to receive either treatment or placebo. A total of 30 subjects will be enrolled and randomized. Group 1 (15 subjects) Fifteen subjects will receive 1 mL of Zofin diluted with 100ml of sterile saline on day 0, day 4 and day 8, containing 2-5 x 10\^11 particles/ml intravenously. Group 2 (15 subjects) Fifteen subjects will receive 1mL of placebo diluted with 100ml of sterile saline on day 0, day 4 and day 8, containing sterile saline intravenously.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Zofin	1mL of Zofin will be administered intravenously, containing 2-5 x 10\^11 particles/mL. Zofin will be diluted in 100 mL of sterile saline.
OTHER	Placebo	1mL of Placebo (normal saline) will be diluted in 100 mL of sterile saline and administered intravenously.

Timeline

• Start date: 2022-04-14
• Primary completion: 2023-10-01
• Completion: 2023-10-18
• First posted: 2022-02-08
• Last updated: 2023-11-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study