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Zofin to Treat COVID-19 Long Haulers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05228899
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : April 15, 2022
Sponsor:
Collaborator:
Proxima Clinical Research, Inc.
Information provided by (Responsible Party):
Organicell Regenerative Medicine

Brief 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 < 12 months) of COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Zofin Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase I/II randomized, double blinded and placebo control. The ratio between groups is 1:1 for total 30 subjects. Each subject will be randomized to receive either treatment or placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Neither the patients nor the researchers know who is getting a placebo and who is getting the treatment.
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : April 14, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Zofin
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.
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.

Placebo Comparator: Group 2: Placebo
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.
Other: Placebo
1mL of Placebo (normal saline) will be diluted in 100 mL of sterile saline and administered intravenously.




Primary Outcome Measures :
  1. Incidence of Severe Adverse Events [ Time Frame: 30 days ]

    To evaluate the safety of Zofin administered intravenously in subjects experiencing prolonged COVID-19 symptoms. To compare the incidence of grade 3 or 4 or serious adverse events (SAEs) in subjects receiving Zofin compared to placebo:

    • Life-threatening event (e.g., stroke or non-fatal pulmonary embolism).
    • Event requiring inpatient hospitalization (e.g., for worsening dyspnea).
    • Event resulting in persistent or significant disability/incapacity.
    • Event resulting in death.


Secondary Outcome Measures :
  1. Fatigue Severity Score Score [ Time Frame: 0, 8,14, 30, 60 days ]
    The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue.

  2. Daily Diary of COVID-19 Related Symptom [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days ]
    Changes in daily COVID-19-Related Symptom Severity Score during the treatment phase

  3. COVID-19 Associated Symptoms Length [ Time Frame: 30 days ]
    Length of COVID-19 associated symptoms from baseline to Day 30 based on self-assessment using daily and weekly symptom diary.

  4. COVID-19 Associated Symptoms Mitigation [ Time Frame: 30 days ]
    Change from baseline through Day 30 of one or more COVID-19 associated symptoms to an improved status

  5. Beck Depression Inventory Score [ Time Frame: 0, 8, 14, 30, 60 days ]
    The Beck Depression Inventory (BDI) is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  6. Mental Fatigue Questionnaire Score [ Time Frame: 0, 8, 14, 30, 60 days ]
    Mental Fatigue Questionnaire Score is a self-reported scale that measure mental fatigue.

  7. Pulse Oxygen Saturation [ Time Frame: 0, 8, 14, 30, 60 days ]
    A Pulse Oxygen Saturation (SpO2) measures how much oxygen is in someone's blood.

  8. Heart Rate Variability by ECG [ Time Frame: 0, 8, 14, 60 days ]
    Change from baseline in Heart Rate Variability by ECG at Days 8, 14, and 60.

  9. Transthoracic echocardiogram [ Time Frame: 0, 8, 60 days ]
    Transthoracic echocardiogram measures of left ventricular function, right ventricular function, and Doppler-derived pulmonary artery pressure.

  10. Frequency of Urgent Care [ Time Frame: 0, 30, 60 days ]
    Number and length of patient's doctor/urgent care/emergency room visit.

  11. C-reactive protein Levels [ Time Frame: 0, 8, 14, 30, 60 days ]
    CRP from serum of blood samples.

  12. D-dimer Levels [ Time Frame: 0, 8, 14, 30, 60 days ]
    D-dimer from serum of blood samples methodology using blood samples

  13. Cytokine Levels [ Time Frame: 0, 8, 14, 30, 60 days ]
    Measure IL-6, TNF-alpha etc from serum of blood samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects age > 18 years at the time of signing the informed consent form.
  2. Male or female.
  3. COVID-19 survivor and had documented SARS-CoV-2 positive (FDA EUA approved RT-PCR).
  4. Subjects with history of COVID-19 infection who are experiencing prolonged fatigue over 6 weeks after their COVID-19 RT-PCR negative test.
  5. Subject has not fully recovered from COVID-19 for at least over 6 weeks despite a negative SARS-COV-02 test.
  6. Subjects tested positive for anti-SARS-CoV-2 antibodies using FDA EUA approved test.
  7. Subject is experiencing the following three symptoms for at least over 6 weeks either continually or intermittently with relapses not experienced pre-illness, that interferes with normal daily activities. Symptoms must be new symptoms i.e., subject didn't have symptoms, and had not sought medical treatment for the symptoms prior to COVID-19:

    • Extreme fatigue - feeling overtired with low energy and a strong desire to sleep but unable to have good sleep.
    • Body aches - muscle soreness or generalized achiness throughout the body.
    • Joint pain - pain in the joints due to inflammation not experienced before illness.
  8. Chalder Fatigue Scale Bimodal Score ≥ 4 at the time of Screening.
  9. Fatigue Severity Scale (FSS) ≥ 4 at the time of Screening.
  10. Fatigue Assessment Scale Score (FAS) ≥ 10.5 at the time of Screening.
  11. Beck Depression Inventory (BDI) score <9 at the time of Screening (score of 9 is an exclusion).
  12. Investigator(s) has access to medical documentation of previous COVID-19 treatments.
  13. Ability of subject to understand and the willingness to sign a written informed consent document.
  14. Subjects must be reasonably able to return for multiple follow-up visits.
  15. Adequate venous access.
  16. For Subjects of Child-Bearing Potential only, willingness to use FDA-recommended birth control until 6 months post-treatment. The FDA-approved and cleared methods for birth control are listed below:

    • Permanent sterilization
    • Long-acting reversible contraceptives (LARC)
    • Contraceptive injection
    • Short-acting hormonal methods
    • Barrier methods
    • Emergency contraception
  17. Any male subject must agree to use contraceptives and not donate sperm during the study.

Exclusion Criteria:

  1. Tested positive for SARS-CoV-2 infection at the time of screening (acute infection) which will involve a nasal swab sample or another FDA-approved test.
  2. Subjects who had recovered fully from COVID-19 and have a new onset of extreme fatigue, body aches, or joint pain that were due to other etiologies, not COVID-19 are excluded.
  3. Subjects with serious co-morbidities are excluded. For example:

    • Liver enzymes are >2X ULN;
    • eGFR is <60 ml/min by the CKD- EPI equation;
    • Hb is <11 mg/dL;
    • Platelet count is <100K;
    • Uncontrolled arrhythmias;
    • BP systolic <90 mmHg or >160 mmHg;
    • Pulse is <60 or >100;
    • Respiratory rate is <12 or >25;
    • Abnormal ECG or any signs of active ischemic heart disease;
    • Heart failure of any degree (including NYHA classification Class 1- 4).
  4. History of migraines prior to COVID-19 infection.
  5. History of neuropathy prior to COVID-19 infection.
  6. History of inflammatory and irritable bowel disease prior to COVID-19 infection.
  7. History of depression and anxiety disorders prior to COVID-19 infection.
  8. History of chronic fatigue syndrome, fibromyalgia, and arthritic disorders prior to COVID-19 infection.
  9. Exhibiting signs of moderate or severe chronic respiratory disease (such as COPD, asthma, or pulmonary fibrosis) and history of these illnesses prior to COVID-19 infection.
  10. Patient with rheumatologic disorders.
  11. History of chronic liver disease or patient showing signs of clinical jaundice at the time of screening.
  12. History of severe chronic kidney disease or requiring dialysis.
  13. Showing signs of severe pneumonia, acute respiratory distress syndrome (ARDS), or respiratory failure needing mechanical ventilation.
  14. Subjects with a history of bleeding disorders or currently on anticoagulation therapy that cannot be stopped prior to infusion which is not related to previous COVID-19 infection.
  15. Oxygen-dependent on nasal canula greater than 2-L per minute.
  16. Patient with pulse oxygen saturation (SpO2) of <94% on room air.
  17. Active or recently treated malignancies.
  18. Any unstable condition of clinical significance, e.g., uncontrolled hypertension, unstable angina pectoris, worsening asthma.
  19. Hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 7 days prior to the screening visit.
  20. Albuterol as nebulizer for the off-label treatment of COVID-19 within 7 days prior to the screening visit
  21. Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
  22. Subject has a body mass index (BMI) greater than 42 kg/m2
  23. Subject has or had an active infection requiring systemic antibiotics within 12 weeks of enrollment in the study
  24. Inability to perform any of the assessments required for endpoint analysis.
  25. Active listing (or expected future listing) for transplant of any organ.
  26. Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
  27. Have a history of organ or cell transplant rejection.
  28. History of drug abuse (illegal "street" drugs except marijuana, if it is legal to use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
  29. Patients with untreated HIV infection. However, patients can be enrolled if have been treated for HIV and the test negative for HIV viral load but still test positive for antibodies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05228899


Contacts
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Contact: Mari Mitrani, MD, PhD (888) 963-7881 clinicaltrials@organicell.com

Locations
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United States, California
NewportNativeMD Recruiting
Newport Beach, California, United States, 92663
Contact: Sarah Serrano, MPH         
United States, Texas
United Memorial Medical Center Recruiting
Houston, Texas, United States, 77091
Contact: Cedar Barrera         
Sponsors and Collaborators
Organicell Regenerative Medicine
Proxima Clinical Research, Inc.
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Responsible Party: Organicell Regenerative Medicine
ClinicalTrials.gov Identifier: NCT05228899    
Other Study ID Numbers: 27378
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Organicell Regenerative Medicine:
COVID-19 Long Hauler
PASC
Zofin
Exosomes
Extracellular Vesicles
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases