A Multi-center, Randomized, Double-blind, Parallel, Placebo-Controlled, Phase Ⅱ Clinical Trial to Evaluate Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients.

Treatment

Study drug: Pyramax (1 tablet , daily for 3 days, Oral)
Comparator drug : Placebo (1 tablet , daily for 3 days, Oral)

Arm Label

Target Number of Participant

Arm Type

Arm Description

Pyramax (1 tablet, daily for 3 days, Oral)

Arm Label

Target Number of Participant

Arm Type

Arm Description

Placebo (1 tablet , daily for 3 days, Oral)

Gender

Age

Description

1)	Male and Female adult age over 19
2)	The weight over 45 kg at screening. 
3)	Persons confirmed by COVID19 as a result of real-time reverse transcription polymerase chain reaction (rRT-PCR) test using specimens collected from upper airway (oropharyngeal/ nasopharyngeal smear mixing, etc.) or lower airway (sputum, etc.)  within 72 hours of randomization.  
4)	Persons whose oxygen saturation in blood (SpO2) > in indoor air condition at randomization.  
5)	A person who agrees in writing to voluntarily decide to participate and follow the precautions after hearing and fully understanding the details of this study.

1)	Persons who are diagnosed with severe pneumonia#
#Suspected respiratory infections with one of the followings
Breathing more than 30 times/minute, severe dyspnea, oxygen saturation (SpO2) 93% or less without oxygen administration
2)	Persons with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation)
3)	Persons with clinically significant anemia (Hemoglobin <8.0 g/dL)
4)	Persons who have hypersensitivity to main ingredients (pyronaridine phosphate, artesunate) and components of the investigational product
5)	Persons who have problems like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 
6)	Persons who have gastrointestinal disease or surgical patient that may affect absorption, distribution, metabolism and excretion of drugs, current active gastritis, gastrointestinal /rectal bleeding, gastric ulcers, pancreatic abnormalities such as pancreatitis, etc. (except simple appendectomy or hernia surgery)  
7)	Persons who have received antiviral drugs for the treatment of COVID19 infection within 28 days prior to participation in the study (However, if sufficient wash-out period has elapsed, it is possible to participate in the study) 
8)	Patients with severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2) 
9)	Patients with severe hepatic impairment (ALT or AST ≥ 5 times the normal upper limit of the trachea or have symptoms of abdominal pain or vomiting associated with Jaundice or Child-Pugh Stage B or C) 
10)	Virus diseases other than COVID19 that requires administration of other antiviral agents (HIV, HBV, HCV etc.) 
11)	Patients requiring mechanical ventilation (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation etc.)
12)	Patients with chronic underlying diseases(such as uncontrolled diabetes, chronic kidney disease, chronic liver disease, chronic lung disease, chronic cardiovascular disease, blood cancer, cancer patients with anti-cancer treatment, patients taking immunosuppressants, etc.), patients with high obesity, dialysis patients, transplant patients whom are inadequate to participate in clinical trials based on the investigator’s discretion.    
13)	Pregnant women or breastfeeding mothers 
14)	Women and men of childbearing potential who plan to become pregnant or unwilling to use the appropriate contraception during the study and within 3 months after completion of the study 
*Hormonal contraception (subcutaneous implants, injection, oral contraceptives, etc.), intrauterine devices(copper IUD, intrauterine systems containing hormones), all use of double-blocking methods (male (condom) and female (contraceptive diaphragm, vaginal sponge or cervical cap), sterilization procedure(vasectomy, ligation of uterine tube, etc.) 
15)	A person who participated in another clinical trial / medical device clinical trial within 28 days from the date of signing the consent and received drug / operated medical device for clinical trial.
16)	A person who has been determined that it is inappropriate to participate in this study for any other reasons by the investigator.

COVID19 virus negative rate (%)

at 7 days after administration of investigational product

Changes in viral load at 3, 7, 10 and 14 days after administration of the investigational product compared to baseline

at 3, 7, 10, 14 days

COVID19 virus negative rate at 3, 10, and 14 days after administration of investigational product (%) *

at 3, 10, 14 days

Changes in the WHO Ordinal Scale for Clinical Improvement at 3, 7, 10, 14 and 28 days after the administration of investigational product.

at 3, 7, 10, 14, 28 days

Changes in NEWS at 3, 7, 10, 14, and 28 days after the administration of investigational product compared to baseline.

at 3, 7, 10, 14, 28 days

Body temperature Normalization† recovery time after administration of investigational product

at 28 days

Respiratory rate Normalization‡ recovery time after administration of investigational product

at 28 days

Oxygen saturation in blood (SpO2) normalization recovery time after administration of investigational product

at 28 days

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