Zofin to Treat COVID-19 Long Haulers

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: ZEO ScientifiX, Inc.

Trial Summary

What is the purpose of this trial?

This trial is testing Zofin, an IV treatment, on people with long-term COVID-19 symptoms. The goal is to see if Zofin can help reduce these prolonged symptoms by using helpful particles. Zofin is derived from full-term perinatal amniotic fluid.

Eligibility Criteria

Inclusion Criteria

Subjects age > 18 years at the time of signing the informed consent form.

You have been feeling tired for more than six weeks after being diagnosed with COVID-19, even though you no longer have the virus.

You had COVID-19 in the past and still feel very tired more than 6 weeks after testing negative for the virus.

See 8 more

Exclusion Criteria

Subjects with a diagnosis of depression upon entry into the study must have had at least 2-months of treatment (psychotherapy, antidepressive medication, or both) prior to enrollment, be stable on their current treatment regimen, and be followed by a medical provider who is actively treating and managing their depression throughout the study period.

People who have severe depression with a score of 15 or higher on a depression scale will not be included.

You have certain health conditions that make you ineligible for the study. These include: liver, kidney or heart disease, low blood pressure, abnormal heart rhythms, low oxygen levels, bleeding disorders, active infections, drug abuse or dependence, uncontrolled migraines or neuropathy, and certain types of cancer. You are also ineligible if you are pregnant, nursing, have a BMI over 42, or have had an organ transplant.

See 3 more

Treatment Details

Interventions

Placebo (Other)
Zofin (Other)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: ZofinExperimental Treatment1 Intervention

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 II: Group 2: PlaceboPlacebo Group1 Intervention

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.