A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression

1. Have any of the contraindications for ARAKODA in the prescribing information including:

1. G6PD deficiency

2. Breastfeeding

3. Psychotic disorder or current psychotic symptoms

4. Known hypersensitivity reaction to TQ

2. Evidence of severe or critical illness, defined by at least one of the following:

1. Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air

2. Respiratory failure defined based on resource utilization requiring at least one of the following: i. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); ii. Shock (defined by systolic blood pressure \<90 mmHg, or diastolic blood pressure \<60 mmHg or requiring vasopressors); iii. Multi-organ dysfunction/failure

3. Any other clinically significant acute illness unrelated to COVID-19 within seven days prior to first study drug administration;

4. Receipt of any approved or experimental small molecule treatment for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation

5. Receipt of any approved or experimental biologic therapeutic for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 90 days prior to the time of the screening evaluation

6. Have been diagnosed (and confirmed by PCR or rapid antigen test) with COVID-19 in the 90 days prior to randomization (other than for this infection);

7. Any excluded concomitant medication as described in the ARAKODA package insert. Receipt of a COVID-19 vaccine is not exclusionary;

8. Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment.

9. Positive pregnancy test;

10. Are ≥65 years of age and have a clinical frailty score \> 5;

11. Have cystic fibrosis;

12. Have received a transplant;

13. Known to be infected with human immunodeficiency virus (HIV);

14. Have received any B-Cell depleting monoclonal antibody in the last six months;

15. Have a disease or condition which in the opinion of the investigator presents an unacceptable risk of disease progression;

16. Have an aggregate symptom score ≥ 15 and any one of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, have never been vaccinated for COVID-19, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance;

17. Have two or more of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance;

18. Have an aggregate symptom score \>32.

What this study is about