Clinical trial: Expanded Access to ZofinTM (OrganicellTM Flow) for Patients With COVID-19 (NCT04657406)

Eligibility criteria:
Inclusion Criteria:

          1. Provide written informed consent

          2. Subjects age > 18 years at the time of signing the Informed Consent Form.

          3. Male or Female

          4. 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

          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:

             In addition to the symptoms patients may get with a mild illness, they may also
             experience:

               -  fever ≥38°

               -  a dry and more persistent cough several times an hour

               -  tiredness and a need to stay in bed

               -  feeling breathless when doing moderate exercise (such as walking upstairs)

               -  muscle pain and aches and need to stay in bed

               -  headache particularly if you are feeling hot

               -  sore throat, soreness from coughing, but no pain

               -  diarrhea

               -  a dry mouth

          6. Adequate venous access

          7. 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:

               -  Permanent Sterilization

               -  Long-Acting Reversible Contraceptives (LARC)

               -  Contraceptive Injection

               -  Short-Acting Hormonal Methods

               -  Barrier Methods

               -  Emergency Contraception

             https://www.fda.gov/consumers/free-publications-women/birth-control

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

          9. Must agree to comply with all protocol requirements and be willing to complete all
             study visits

        Exclusion Criteria:

          1. Patients who have moderate to severe respiratory distress syndrome due to COVID-19

          2. 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.

          3. Inability to perform any of the assessments required.

          4. Active listing (or expected future listing) for transplant of any organ.

          5. 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.

          6. 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

          7. 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.
No condition on gender to be admitted to the trial.

Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment