Expanded Access to Zofin for Patients With COVID-19

This is an expanded access trial for Covid19 focused on measuring Human, Exosomes, Human Amniotic Fluid Read More

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.