Zofin (Organicell Flow) for Patients With COVID-19

NCT04384445 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 19881
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 COVID-19 infection vs Placebo.

Conditions

Corona Virus Infection; COVID-19; SARS; Acute Respiratory Distress Syndrome

Keywords

Human Amniotic Fluid; Exosomes; Human

Outcome Measures

Primary Outcomes (2)

• Incidence of any infusion associated adverse events

  Safety will be defined by the incidence of any infusion associated adverse events as assessed by treating physician

  60 Days

• Incidence of Severe Adverse Events

  Safety will be defined by the incidence of severe adverse events as assessed by treating physician

  60 Days

Secondary Outcomes (8)

• All Cause Mortality

  60 Days

• Survival Rate

  60 Days

• Cytokine Levels

  Day 0, Day 4, Day 8, Day14, Day 21, Day 28

• D-dimer Levels

  Day 0, Day 4, Day 8, Day14, Day 21, Day 28

• C-reactive protein Levels

  Day 0, Day 4, Day 8, Day14, Day 21, Day 28

Study Arms (2)

Zofin Plus Standard Care

EXPERIMENTAL

Participants in this group will receive standard of care plus Zofin on day 0, day 4 and day 8.

Biological: Zofin

Placebo Plus Standard Care

PLACEBO COMPARATOR

Participants in this group will receive standard of care plus placebo (Saline) on day 0, day 4 and day 8.

Other: Placebo

Interventions

Zofin BIOLOGICAL

Biological: Zofin will be administered intravenously with 1ml, containing 2-5 x 10\^11 particles/mL in addition to the Standard Care. The Zofin dose will be diluted in 100 mL of sterile saline at subject's bedside.

Zofin Plus Standard Care

Placebo OTHER

Other: Placebo Placebo (saline) will be administered intravenously with 1ml in addition to the Standard Care. The Placebo dose will be diluted in 100 mL of sterile saline at subject's bedside.

Placebo Plus Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZEO ScientifiX, Inc.: lead

Study Sites (1)

George C. Shapiro

New York, New York, 10604, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• George C Shapiro, MD, FACC

  Chief Medical Officer at Organicell Regenerative Medicine, Inc

  PRINCIPAL INVESTIGATOR

• Maria Ines Mitrani, MD, PhD

  Chief Science Officer at Organicell Regenerative Medicine, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind: neither subjects nor the investigators who are assessing the patient are award of the treatment assignment until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial has two groups, each with 10 subjects (n=20). All eligible study subjects will be randomized, double blinded, to either the treatment group or placebo group.

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 12, 2020
• Study Start: September 8, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)