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Zofin for Coronavirus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Coronavirus+5 MoreZofin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to see if Zofin is safe and effective in people with long-term COVID-19 symptoms.

Eligible Conditions
  • Coronavirus

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 13 Secondary · Reporting Duration: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days

Day 28
Daily Diary of COVID-19 Related Symptom
0, 30, 60 days
Frequency of Urgent Care
Day 21
C-reactive protein Levels
Cytokine Levels
D-dimer Levels
Day 60
Beck Depression Inventory Score
Mental Fatigue Questionnaire Score
Day 60
Heart Rate Variability by ECG
0, 8, 60 days
Transthoracic echocardiogram
Day 60
Fatigue Severity Score Score
Day 60
Pulse Oxygen Saturation
30 days
COVID-19 Associated Symptoms Length
COVID-19 Associated Symptoms Mitigation
Incidence of Severe Adverse Events

Trial Safety

Safety Progress

1 of 3

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1
Q-GRFT Nasal Spray
1
Tocilizumab
1
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Trial Design

2 Treatment Groups

Group 1: Zofin
1 of 2
Group 2: Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Zofin · Has Placebo Group · Phase 1 & 2

Group 1: Zofin
Drug
Experimental Group · 1 Intervention: Zofin · Intervention Types: Drug
Group 2: Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days

Who is running the clinical trial?

Organicell Regenerative MedicineLead Sponsor
3 Previous Clinical Trials
40 Total Patients Enrolled
Proxima Clinical Research, Inc.UNKNOWN
1 Previous Clinical Trials
265 Total Patients Enrolled
Kirstein BoylenStudy DirectorProxima
Kristen BoylenStudy DirectorProxima
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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 joint pain that does not occur before illness.
You feel tired, fatigued, and unable to function normally.

Who else is applying?

What state do they live in?
Pennsylvania100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
United Memorial Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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