Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

Study Overview
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Brief Summary
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This study is a multi-center, single-arm, open-label, pilot clinical trial to explore efficacy and safety of Pyramax in mild to moderate COVID-19 patients

Detailed Description
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This study is a multi-center, single-arm, open-label, pilot clinical trial to explore the efficacy and safety of Pyramax Tab. in patients diagnosed with mild to moderate Coronavirus Disease-19 (COVID-19). Major inclusion criteria are eligible patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before the screening, who do not need adjunctive oxygen therapy. Subjects eligible to participate in this study will be enrolled and will take Investigational Product once a day for 3 days. Subjects will participate in this study for 29 days in total, and subjects will follow the procedure in accordance with the Schedule of Clinical Trial Events to evaluate efficacy and safety after administration of Investigational Product. Even though subjects are released from quarantine or discharged after showing clinical improvements, subjects should continue to visit hospitals for follow-up until 29 days in accordance with scheduled visit. The criteria of specific discharge (release from quarantine) for confirmed COVID-19 patients with symptoms should follow the latest version of the infectious disease prevention and control guideline.

Official Title
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A Multi-Center Single Arm, Open-label, Pilot Clinical Trial to Explore 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 years or older Patients with body weight ≥45 kg at screening Patients who were first confirmed with COVID-19 through Real-Time Polymerase Chain Reaction (RT-PCR) or antigen test within 96 hours of baseline (those who have no history of confirmed COVID-19 within 3 months from the time of screening) Patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before screening, 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 or higher level of care, or who may be potentially transferred to another hospital other than the institution within 72 hours, with decreased oxygen saturation (<94%) at screening. Patients who have received or who have plans 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 Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of 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 investigational product Pregnant, breast-feeding or females with positive pregnancy test at screening Females and males who have a child-bearing plan or who are unwilling to commit to the use of the highly effective methods of contraception during the study period and for 3 months after the study period, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence and surgical sterilization (vasectomy, tubal ligation, etc.) 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pyramax<br>pyronaridine-artesunate (180/160 mg) | Drug: Pyramax<br>* Participant body weight ≥65 kg (Pyramax 4 tablets) ≥45 kg and <65 kg (Pyramax 3 tablets)<br>* Other names: pyronaridine-artesunate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product | Time took for subjects with positive infectious viable virus from virus culture at the baseline to get first negative infectious virus test result | follow up to Day29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in SARS-CoV-2 infectious virus titer by viral culture | Changes in COVID-19 infectious viral titer compared to the baseline | follow up to Day14 | 
| Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR | Changes in COVID-19 viral RNA load compared to the baseline | follow up to Day14 | 
| Percentage of subjects requiring acute treatment for more than 24 hours in a hospital or acute treatment facility due to COVID-19 or who have died until 29 days after administration | Proportion of participants with progression to severe COVID-19 through Day 29 assessed by the composite outcome of COVID-19-related adjudicated hospitalization or oxygen therapy or more extensive care or death from any cause | follow up to Day29 | 
| Percentage of patients with new and aggravated pneumonia until 29 days after administration of the investigational product | Defined as new occurrence or aggravation of existing pneumonia | 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, SARS-CoV-2