Status:
COMPLETED
Zofin (Organicell Flow) for Patients With COVID-19
Lead Sponsor:
ZEO ScientifiX, Inc.
Conditions:
Corona Virus Infection
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Zofin for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to CO...
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 r...
Eligibility Criteria
Inclusion
- 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, with at least one of clinical symptoms (e.g., fever ≥38°C, fatigue, cough) and a positive result by the reverse- transcription polymerase chain reaction (RT-PCR) testing or equivalent.
- Individuals with moderately to severe COVID-19 symptoms.
- Moderate ARDS according to Berlin Criteria:
- Symptoms include: abnormal chest imaging or any degree of hypoxia requiring supplemental oxygen. Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules. Oxygenation: 100 mm Hg \< PaO2/FIO2 \</= 200 mm Hg with PEEP \>/=5 cm H2O
- Severe ARDS according to Berlin Criteria:
- Symptoms include: abnormal chest imaging or any degree of hypoxia requiring supplemental oxygen. Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules. Oxygenation: PaO2/FIO2 \</= 100 mm Hg with PEEP \>/= 5 cm H2O
- Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
- Adequate venous access
- Ability to provide informed consent or an authorized representative can sign the informed consent
- For female patients only, willingness to use FDA- recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAu dience/ForWomen/FreePublications/UCM356451.pdf ) until 6 months post treatment.
- Must agree to comply with all study requirements and be willing to complete all study visits
- Willingness of study participant to accept this treatment arm, and signed informed consent; Need in- patient admission.
Exclusion
- Intubated or on a ventilator.
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
- Inability to perform any of the assessments required for endpoint analysis.
- 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, 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
- Be serum positive for HIV, hepatitis BsAg or hepatitis C.
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04384445
Start Date
September 8 2020
End Date
July 1 2023
Last Update
November 1 2023
Active Locations (1)
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1
George C. Shapiro
New York, New York, United States, 10604