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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical trial to evaluate the safety, PK, viral shedding and clinical effects of Pentarlandir™ UPPTA in patients with early COVID-19. Approximately 90 ambulatory subjects with mildly symptomatic early COVID-19, who have been diagnosed with COVID-19 within the prior 4 days will be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SyneuRx International (Taiwan) Corp

Criteria

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 monitoring devices per the Investigator.

4. Early COVID-19 diagnosis with mild severity defined as meeting all of the below:

1. Confirmation of COVID-19 by a PCR-based diagnostic within 4 days of randomization.

• COVID-19 with mild symptoms, defined as a score of 8 or higher on the clinical 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 is rated 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 or chest CT.

3. Resting RR ≤ 20, HR ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air.

5. For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]):

1. Negative urine pregnancy test at screening.

2. 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 relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication.

6. Ability and willingness to comply with all aspects of the study through the entire study period.

Exclusion Criteria:

1. Patient is either asymptomatic or with baseline severity of moderate, sever, or critical 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 disease progression of COVID-19.

5. Signs or symptoms indicative of pneumonia or any other lower respiratory tract disorders, or clinically significant findings in available lung imaging studies suggestive 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 of COVID-19.

8. Use of remdesivir, chloroquine, hydroxychloroquine, convalescent plasma, other monoclonal antibody therapies, include REGEN-COV (casirivimab and imdevimab), bamlanivimab (plus etesevimab), dexamethasone, ivermectin, baricitinib, and other Janus kinase inhibitors, Bruton's tyrosine kinase inhibitors, tocilizumab (and other interleukin-6 inhibitors) and any other therapy with EUA or approval and other investigational agents for COVID-19.

9. Patients who are participating in other clinical trials.

10. History of conditions associated with immunocompromise, or treatments known to affect the 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 tannic acid as active ingredient.

13. Any unstable or uncontrolled medical illnesses such as neurological disorders, cardiovascular disorders, diabetes, hepatic or renal disorders that per the Investigator would intervene with the study conduct or study results interpretation.

14. Any other medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a patient's ability to give informed consent or respond to the study procedures or questions during the personal visits or the video calls.

15. High-risk individuals are those who meet at least one of the following criteria:

1. Aged ≥ 65 years

2. Body mass index (BMI) > 30

3. Pregnancy

4. Chronic kidney disease

5. Diabetes

6. Immunosuppressive disease or immunosuppressive treatment

7. Cardiovascular disease (including congenital heart disease) or hypertension

8. Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)

9. Sickle cell disease

10. Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)

11. Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]

12. Exclusion is not limited to the medical conditions or factors listed above. The investigators have to consider the benefit-risk for an individual patient to determine other medical conditions or factors (for example, overweight, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and be excluded.