AVAILABLENot Applicable

Expanded Access to Zofin for Patients With COVID-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.
✓. 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:
✓. Any male subject must agree to use contraceptives and not donate sperm during the study.

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.

Trial details

NCT IDNCT04657406

SponsorZEO ScientifiX, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

Mari Mitrani, MD, PhD

888-963-7881 clinicaltrials@organicell.com

View on ClinicalTrials.gov More Covid19 trials