NCT04657406

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

First QC Date

December 3, 2020

Last Update Submit

March 21, 2023

Conditions

Covid19Corona Virus InfectionSARS (Severe Acute Respiratory Syndrome)Acute Respiratory Distress Syndrome

Keywords

HumanExosomesHuman Amniotic Fluid

Interventions

ZofinDRUG

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.

Also known as: Organicell Flow

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (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 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:
  • +21 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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MeSH Terms

Conditions

COVID-19Coronavirus InfectionsSevere Acute Respiratory SyndromeRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Mari Mitrani, MD, PhD

CONTACT

888-963-7881clinicaltrials@organicell.com

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 8, 2020

Last Updated

March 23, 2023

Record last verified: 2023-03