The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients (Phase3)

Study Overview
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Brief Summary
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This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase III clinical trial to evaluate efficacy and safety of pyramax in mild to moderate COVID-19 patients.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Pyramax
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and females aged 19 years or older (or minimum age for adulthood or for informed consent below 19 years for each country) Patients with body weight ≥45 kg at screening Patients with COVID-19 confirmed by RT-PCR before randomization Patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days before randomization, who do not need adjunctive oxygen therapy Patients who are fully informed of this study, voluntarily decide to participate in this study and provide written consent to comply with requirements for this study Exclusion Criteria: Patients with severe or critical* COVID-19 Patients requiring hospitalization for therapeutic purposes for COVID-19 such as oxygen therapy with a decrease of oxygen saturation (<94%) at screening or higher level of care, or who may be potentially transferred to another hospital other than the clinical trial institution within 72 hours. Patients who have received or who have planned to receive any anti-viral drugs to treat COVID-19 infection or medications that may affect the course of treatment within 28 days before participating in this study or before a sufficient wash-out period [more than five times the half-life of the drug, etc.] (the longer period between the two is chosen). Patients with one or more of the following infections in the past or present Infection with need for systemic anti-infection treatment other than Corona virus (SARS-CoV-2) Major infection with need for oral antibiotics or hospitalization within 30 days before administration of the investigational product by discretion of the investigator. Patients with a known clinically significant anemia (Hemoglobin <8.0 g/dL) Patients with a known severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2) Patients with a known severe hepatic dysfunction Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of the investigational product Patients with a gastrointestinal disease or who underwent a surgery that can affect the absorption, distribution, metabolism and excretion of the drug, or who have active gastritis, gastrointestinal tract/rectal bleeding, gastric ulcer, and pancreatitis or pancreatic function abnormalities (excluding general appendectomy or hernia repair surgery) Patients who cannot be orally administered with the Investigational Product Pregnant, breast-feeding or females with positive pregnancy test at screening Females and males who have child-bearing plan or who are unwilling to commit to the use of the following methods of contraception* during study period and for 3 months after the study period Patients who have participated in another clinical study/device study and received the investigational product/device within 28 days from signing the informed consent Patients with Co-morbidity requiring surgery within 7 days before administration of the investigational product, or life-threatening co-morbidity within 30 days before administration of the investigational product Patients with history of alcohol or drug abuse within 12 months before administration of the investigational product Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Pyramax tablet | Drug: Pyramax<br>* Pyronaridine-Artesunate(180/60mg) tablet for 3days.<br>|
| Placebo Comparator: Control<br>Placebo tablet | Drug: Placebo<br>* Placebo tablet for 3days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29. |  | follow up to Day29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sustained recovery (discharge) in hospitalized subjects (days) |  | follow up to Day29 | 
| 29-day mortality after the first dose of the investigational product |  | Day29 | 
| 11-point WHO clinical progression scale for clinical symptoms at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline |  | Day3, Day7, Day14, Day21, Day29 | 
| NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline |  | Day3, Day7, Day14, Day21, Day29 | 
| Percentage of subjects requiring acute therapy for more than 24 hours in a hospital or acute treatment facility or who have died due to COVID-19 until D29 after administration |  | follow up to Day29 | 
| Percentage of subjects who have newly diagnosed with pneumonia or aggravated pneumonia* according to baseline pneumonia criteria until D29 after administration of the IP |  | follow up to Day29 | 
| Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14 |  | Day2, Day3, Day5, Day7, Day14 | 
| Percentage of subjects in the high-risk group** who require hospitalization or have died due to COVID-19 until post-dose D29 |  | follow up to Day29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pyramax, Pyronaridine, Artesunate, COVID-19, Corona virus