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Zofin (Organicell Flow) for Patients With COVID-19

NCT04384445 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-01

No results posted yet for this study

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

Interventions

BIOLOGICAL

Zofin

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • ZEO ScientifiX, Inc.

    lead INDUSTRY

Principal Investigators

  • George C Shapiro, MD, FACC · Chief Medical Officer at Organicell Regenerative Medicine, Inc

  • Maria Ines Mitrani, MD, PhD · Chief Science Officer at Organicell Regenerative Medicine, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2023-07-01
Completion
2023-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04384445 on ClinicalTrials.gov