Expanded Access to Zofin for Patients With COVID-19
Primary Purpose
Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome)
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Zofin
Sponsored by
About this trial
This is an expanded access trial for Covid19 focused on measuring Human, Exosomes, Human Amniotic Fluid
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent
- Subjects age > 18 years at the time of signing the Informed Consent Form.
- Male or Female
- Must have a clinical diagnosis of COVID-19 by the qualitative reverse-transcription polymerase chain reaction (RT-PCR), with at least one of mild or moderate COVID-19 clinical symptoms which are defined below in #5
Individuals with mild to moderately COVID-19 symptoms for outpatient and inpatient population.
The main symptoms of mild illness are:
- low grade fever <38°C (37.5 to 37.9)
- a dry cough
- tiredness
- feeling slightly breathless
- muscle pain
- headache
- sore throat
- diarrhea
The main symptoms of moderate illness are:
In addition to the symptoms patients may get with a mild illness, they may also experience:
- fever ≥38°
- a dry and more persistent cough several times an hour
- tiredness and a need to stay in bed
- feeling breathless when doing moderate exercise (such as walking upstairs)
- muscle pain and aches and need to stay in bed
- headache particularly if you are feeling hot
- sore throat, soreness from coughing, but no pain
- diarrhea
- a dry mouth
- Adequate venous access
For Women of Child-Bearing Potential (WOCBP) 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
https://www.fda.gov/consumers/free-publications-women/birth-control
- Any male subject must agree to use contraceptives and not donate sperm during the study.
- Must agree to comply with all protocol requirements and be willing to complete all study visits
Exclusion Criteria:
- Patients who have moderate to severe respiratory distress syndrome due to COVID-19
- 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.
- Inability to perform any of the assessments required.
- Active listing (or expected future listing) for transplant of any organ.
- 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. Have a history of organ or cell transplant rejection.
- History of drug abuse (illegal "street" drugs except marijuana (If it is legal 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
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04657406
First Posted
December 3, 2020
Last Updated
March 21, 2023
Sponsor
Organicell Regenerative Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04657406
Brief Title
Expanded Access to Zofin for Patients With COVID-19
Official Title
Expanded Access to Zofin for the Treatment of Patients With Mild to Moderate COVID-19 Due to SARS-Cov-2 for Outpatient and Inpatient Population
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organicell Regenerative Medicine
4. Oversight
5. Study Description
Brief Summary
This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease.
Detailed Description
A human coronavirus (HCoV-19) has caused the novel coronavirus disease (COVID-19) outbreak worldwide. Common symptoms of COVID-19 include fever, cough, and shortness of breath. The majority of cases result in mild symptoms, but some can progress into pneumonia and multi-organ failure. According to the severity it is divided into mild, normal, severe and critically ill, which is associated with ICU admission and mortality. At present, the standard treatment of COVD-19 patients is oxygen therapy, mechanical ventilation, and medications to maintain blood pressure. As of today, no specific antiviral therapy is available for patients with COVID-19. Immune activation in some patients, and the appearance of cytokine storm syndrome (CSS) is one of the important causes of severe damage to lungs and other organs, which may lead to death. There is an urgent need to develop new interventions to suppress the excessive immune response in a timely manner during the course of disease, protect alveolar function, and reduce lung and systemic organ damage.
Zofin is an acellular, minimally manipulated product, derived from human amniotic fluid (HAF). This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from amniotic stem and epithelial cells. The product contains a mean concentration of 5.24x10^11 particles/mL with a mean mode size of 125.2nm. Surface marker analysis confirmed the presence of exosome associated proteins CD63, CD81, and CD9 in addition to high expression of CD133. The completed sequencing revealed 102 commonly expressed miRNA (with a 100-copy expression minimum). Bioinformatics analysis linked 63 miRNAs to 1216 RNA targets. Major players in the proinflammatory cytokine cascade found to be targeted by miRNA were discovered in Organicell's product include TNF, IL-6, and IL-8. Additionally, a broader array of pro-inflammatory cytokines is also targeted by the collection of miRNA such as FGF2, IFNB1, IGF1, IL36a, IL37, TGF-B2, VEGFA, CCL8, and CXCL12. It has been suggested in published research that inhibition or suppression of this pro-inflammatory cytokine cascade may reduce the severity of symptoms associated with elevated immune response. Furthermore, the miRNA was found to target 148 genes associated with immune response.
The property of Zofin demonstrates the therapeutic potential as a suppressor of cytokine activation for the reduction of COVID-19 infection severity. This is an open label expanded access protocol to treat subjects using ZofinTM (OrganicellTM Flow) for treatment of mild to moderate COVID-19 due to SARS-Cov-2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), Acute Respiratory Distress Syndrome
Keywords
Human, Exosomes, Human Amniotic Fluid
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zofin
Other Intervention Name(s)
Organicell Flow
Intervention Description
Subjects will receive standard of care plus 1 mL of Zofin on day 0, day 4 and day 8, containing 1-5 x 10^11 particles/mL.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent
Subjects age > 18 years at the time of signing the Informed Consent Form.
Male or Female
Must have a clinical diagnosis of COVID-19 by the qualitative reverse-transcription polymerase chain reaction (RT-PCR), with at least one of mild or moderate COVID-19 clinical symptoms which are defined below in #5
Individuals with mild to moderately COVID-19 symptoms for outpatient and inpatient population.
The main symptoms of mild illness are:
low grade fever <38°C (37.5 to 37.9)
a dry cough
tiredness
feeling slightly breathless
muscle pain
headache
sore throat
diarrhea
The main symptoms of moderate illness are:
In addition to the symptoms patients may get with a mild illness, they may also experience:
fever ≥38°
a dry and more persistent cough several times an hour
tiredness and a need to stay in bed
feeling breathless when doing moderate exercise (such as walking upstairs)
muscle pain and aches and need to stay in bed
headache particularly if you are feeling hot
sore throat, soreness from coughing, but no pain
diarrhea
a dry mouth
Adequate venous access
For Women of Child-Bearing Potential (WOCBP) 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
https://www.fda.gov/consumers/free-publications-women/birth-control
Any male subject must agree to use contraceptives and not donate sperm during the study.
Must agree to comply with all protocol requirements and be willing to complete all study visits
Exclusion Criteria:
Patients who have moderate to severe respiratory distress syndrome due to COVID-19
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.
Inability to perform any of the assessments required.
Active listing (or expected future listing) for transplant of any organ.
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. Have a history of organ or cell transplant rejection.
History of drug abuse (illegal "street" drugs except marijuana (If it is legal 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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mari Mitrani, MD, PhD
Phone
888-963-7881
Email
clinicaltrials@organicell.com
12. IPD Sharing Statement
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