The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients

Inclusion Criteria:

1. Male and female adults age (≥19 years at the time of informed consent)
2. Body weight (≥ 45 kg at Screening)
3. Participants must be confirmed as having COVID-19 using real-time reversetranscription polymerase chain reaction (RT-PCR) test and specimens collected fromupper airway (nasopharyngeal specimen) within 96 hours prior to randomization.
4. Females must be non-pregnant and non-lactating, and must use an acceptable, highlyeffective double contraception from Screening until study completion, including thefollow-up period. Males must be surgically sterile (>30 days since vasectomy with noviable sperm), abstinent, or if engaged in sexual relations with a woman ofchildbearing potential (WOCBP), the participant and his partner must be surgicallysterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateraloophorectomy) or using an acceptable, highly effective contraceptive method fromScreening until study completion, including the follow-up period.

• Hormonal contraception (with approved oral contraceptives, long-actingimplantable hormones, injectable hormones), intra uterine device, condoms ,sterilization (vasectomy, tubal occlusion, etc.)

Exclusion Criteria:

1. Participants with clinically significant cardiovascular disease (including arrhythmia,corrected QT interval prolongation [QTcF> 470 msec for females, or >450 msec formales, at Screening])
2. Participants with clinically significant anemia (Hemoglobin <8.0 g/dL)
3. Participants who have hypersensitivity to main ingredients (pyronaridinetetraphosphate, artesunate) and any excipient in the IP
4. Participants who have gastrointestinal disease or surgical participant that may affectabsorption, distribution, metabolism and excretion of drugs, current active gastritis,gastrointestinal /rectal bleeding, gastric ulcers, pancreatic abnormalities such aspancreatitis, etc. (simple appendectomy or hernia surgery not excluded)
5. Participants who have received antiviral drugs for the treatment of COVID-19 infectionor other indications within 28 days prior to participation in the study or who havenot had sufficient wash-out period of the antiviral drugs
6. Participants with severe renal impairment (estimated glomerular filtration rate ≤30mL/min/1.73 m2)
7. Participants with severe hepatic impairment (Alanine aminotransferase or Aspartateaminotransferase ≥5x upper limit of normal) or have symptoms of abdominal pain orvomiting associated with Jaundice or Child-Pugh Stage B or C
8. Viral infections other than COVID-19 that requires administration of other antiviralagents (for example but not limited to human immunodeficiency virus, hepatitis Bvirus, hepatitis C virus)
9. Participants requiring mechanical ventilation (e.g. non-invasive ventilation, invasivemechanical ventilation, extracorporeal membrane oxygenation etc.). However, those whocan be given oral administration are not exdluded.
10. Participants with chronic underlying diseases (such as uncontrolled diabetes, chronickidney disease, chronic liver disease, chronic lung disease [including asthma, chronicobstructive pulmonary disease and tuberculosis], chronic cardiovascular disease, bloodcancer, cancer participants with anti-cancer treatment, participants takingimmunosuppressants, etc.), participants with high obesity (BMI > 40), dialysisparticipants, transplant participants whom are inadequate to participate in clinicaltrials based on the Investigator's discretion.
11. Pregnant or lactating at Screening or planning to become pregnant (self or partner) atany time during the study, including the follow-up period.
12. Participants who participated in another clinical trial / medical device clinicaltrial within 28 days from the date of signing the consent and received drug / operatedmedical device for clinical trial.
13. Participants who the Investigator has deemed inappropriate for inclusion in this studyfor any other reason.
14. Prior or ongoing medical conditions, medical history, physical findings, or laboratoryabnormality that, in the Investigator's (or delegate's) opinion, could adverselyaffect the safety of the participant.