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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days
Summary
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.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Severe Adverse Events
Secondary study objectives
Beck Depression Inventory Score
C-reactive protein Levels
COVID-19 Associated Symptoms Length
+10 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zofin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
ZEO ScientifiX, Inc.Lead Sponsor
3 Previous Clinical Trials
40 Total Patients Enrolled
Proxima Clinical Research, Inc.UNKNOWN
1 Previous Clinical Trials
203 Total Patients Enrolled
Organicell Regenerative MedicineLead Sponsor
3 Previous Clinical Trials
40 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been feeling tired for more than six weeks after being diagnosed with COVID-19, even though you no longer have the virus.People who have severe depression with a score of 15 or higher on a depression scale will not be included.You had COVID-19 in the past and still feel very tired more than 6 weeks after testing negative for the virus.Anyone can participate regardless of gender.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.You have a score of 4 or more on the Chalder Fatigue Scale.You have a positive test for SARS-CoV-2.You have not fully recovered from COVID-19 for at least over 6 weeks.You have been experiencing extreme fatigue, body aches, and joint pain for at least 6 weeks, which interferes with your daily activities. You did not have these symptoms before getting COVID-19. You will be asked to complete some questionnaires to assess the severity of your symptoms. You also need to have access to medical documentation of previous COVID-19 treatments and be willing to participate in multiple follow-up visits. You must be able to understand and sign a consent form, and have adequate venous access.You cannot have thoughts of hurting yourself or others.You recently had COVID-19, but now you are experiencing severe tiredness, body aches, or joint pain that are not related to COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Zofin
- Group 2: Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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