Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19

Inclusion Criteria:

1. Men and women 18 years of age or older.
2. Able and willing to provide informed consent.
3. Able and willing to sufficiently operate smart phones and study-provided monitoringdevices per the Investigator.
4. Early COVID-19 diagnosis with mild severity defined as meeting all of the below:
5. Confirmation of COVID-19 by a PCR-based diagnostic within 4 days ofrandomization.

• COVID-19 with mild symptoms, defined as a score of 8 or higher on theclinical symptom score.
• Clinical symptom score includes 9 items in fever or chills, myalgia, cough,headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose,and fatigue (malaise) as assessed and recorded by the investigator. Note: The total score per patient ranges from 0 to 27 points. Each symptom israted from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe]

2. No signs of a more serious lower airway disease per clinical exam, chest X-ray orchest CT.
3. Resting RR ≤ 20, HR ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air.
4. For women of childbearing potential (women who are not permanently sterile [documentedhysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] orpostmenopausal [12 months with no menses without an alternative medical cause]):
5. Negative urine pregnancy test at screening.
6. Willingness to practice a highly effective method of contraception that includes,but is not limited to, abstinence, sex only with persons of the same sex,monogamous relationship with a postmenopausal partner, monogamous relationshipwith vasectomize partner, vasectomy, licensed hormonal methods, intrauterinedevice, or consistent use of a barrier method (e.g., condom, diaphragm) withspermicide for 28 days after the last dose of study medication.
7. Ability and willingness to comply with all aspects of the study through the entirestudy period.

Exclusion Criteria:

1. Patient is either asymptomatic or with baseline severity of moderate, sever, orcritical COVID-19.
2. Pregnant or lactating women.
3. Patients with shortness of breath at rest.
4. Findings on physical examination or available imaging studies suggesting rapid diseaseprogression of COVID-19.
5. Signs or symptoms indicative of pneumonia or any other lower respiratory tractdisorders, or clinically significant findings in available lung imaging studiessuggestive of such disorders.
6. Need for immediate hospitalization, oxygen supplementation or mechanical ventilation.
7. Obstructive airway diseases, including chronic obstructive pulmonary disease (COPD)and asthma, or other respiratory disease that could exacerbate independent ofCOVID-19.
8. Use of remdesivir, chloroquine, hydroxychloroquine, convalescent plasma, othermonoclonal antibody therapies, include REGEN-COV (casirivimab and imdevimab),bamlanivimab (plus etesevimab), dexamethasone, ivermectin, baricitinib, and otherJanus kinase inhibitors, Bruton's tyrosine kinase inhibitors, tocilizumab (and otherinterleukin-6 inhibitors) and any other therapy with EUA or approval and otherinvestigational agents for COVID-19.
9. Patients who are participating in other clinical trials.
10. History of conditions associated with immunocompromise, or treatments known to affectthe immune system, including but not limited to oral or intravenous corticosteroids,alkylating drugs, antimetabolites, cytotoxic drugs, other chemotherapy, radiation,immune-modulating biologics, within 30 days of screening.
11. Barium enemas within the last 30 days.
12. Taking OTC or prescribed medicine which has compound as active ingredient.
13. Any unstable or uncontrolled medical illnesses such as neurological disorders,cardiovascular disorders, diabetes, hepatic or renal disorders that per theInvestigator would intervene with the study conduct or study results interpretation.
14. Any other medical, psychiatric, or social condition or occupational or otherresponsibility that in the judgment of the Investigator would interfere with or serveas a contraindication to protocol adherence, assessment of safety, or a patient'sability to give informed consent or respond to the study procedures or questionsduring the personal visits or the video calls.
15. High-risk individuals are those who meet at least one of the following criteria:
16. Aged ≥ 65 years
17. Body mass index (BMI) > 30
18. Pregnancy
19. Chronic kidney disease
20. Diabetes
21. Immunosuppressive disease or immunosuppressive treatment
22. Cardiovascular disease (including congenital heart disease) or hypertension
23. Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonaryhypertension)
24. Sickle cell disease
25. Neurodevelopmental disorders (for example, cerebral palsy) or other conditionsthat confer medical complexity (for example, genetic or metabolic syndromes andsevere congenital anomalies)
26. Having a medical-related technological dependence (for example, tracheostomy,gastrostomy, or positive pressure ventilation [not related to COVID-19]
27. Exclusion is not limited to the medical conditions or factors listed above. Theinvestigators have to consider the benefit-risk for an individual patient todetermine other medical conditions or factors (for example, overweight, race orethnicity) may also place individual patients at high risk for progression tosevere COVID-19 and be excluded.