The 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, randomized, double-blind, parallel, placebo-controlled, phase Ⅱ 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 Ⅱ 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: Pyronaridine-Artesunate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥19 years at the time of signing Informed Consent Form Body weight ≥45 kg at screening Laboratory (rRT-PCR) confirmed infection with SARS-CoV-2 by testing specimens from upper airway (i.e. nasopharyngeal and oropharyngeal swab) or lower airway (i.e. sputum) within 96 hours of randomization Oxygen saturation(SpO2) > 94% at randomization, in room air condition Willing and able to provide informed consent Exclusion Criteria: Diagnosed with severe pneumonia Patients with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation) Patients with clinically significant anemia (Hemoglobin <8.0 g/dL) Patient with known allergic reaction or contraindication to any of the investigational medicinal product (pyronaridine tetraphosphate, artesunate) Patients with known history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc. Patients with the gastrointestinal disease and surgery to affect the absorption, distribution, metabolism and excretion of the drug, active gastritis, gastrointestinal tract / rectal bleeding, gastric ulcer, pancreatitis abnormalities (except simple appendectomy or hernia surgery) Patients who received antiviral drugs that is intended to treat COVID-19, within 28 days prior to screening evaluation (can be enrolled into the study, if the patient has gone through a sufficient wash-out period) Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) Patients with known severe liver disease (i.e. ALT or AST>5 times upper limit, nausea, abdominal pain associated with jaundice or Child-Pugh stage B or C) Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of other antiviral agents Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.) Patients with chronic underlying disease (e.g. uncontrolled diabetes mellitus, chronic kidney disease, chronic liver disease, chronic pulmonary disease, chronic cardiovascular disease, blood cancer, cancer patients with cancer treatment, patients taking immunosuppressants), highly obese patients, dialysis patients, and transplant patients that are determined by the Physician, to be not suitable for trial involvement. Pregnant or lactating women Male or female of childbearing potential who has plans to become pregnant during the study period and for three months after the clinical study or who is not willing to take appropriate contraceptive measures *Hormonal contraception (contraceptive implant, injections, pills, etc.), IUDs, condoms (male) and contraceptive diaphragm or cap (female), sterilization (vasectomy, tubal ligation, etc.) Participating in another clinical trial currently or within 28 days from signing the informed consent Patients that are deemed ineligible to participate in the clinical trial by the Investigator

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: Arm A<br>Pyramax (Pyronaridine 180mg/ Artesunate 60mg) | Drug: Pyronaridine-Artesunate<br>* Pyramax<br>|
| Placebo Comparator: Arm B<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose* | * Patients who are rRT-PCR negative for COVID-19 | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline |  | Day 3, 7, 10, 14 | 
| Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose* | * Patients who are rRT-PCR negative for COVID-19 | Day 3, 10, 14 | 
| Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline |  | Day 3, 7, 10, 14, 28 | 
| Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline |  | Day 3, 7, 10, 14, 28 | 
| Time to achieve normalization of body temperature, post-dose |  | Day 3, 7, 10, 14, 28 | 
| Time to achieve normalization of respiratory rate, post-dose |  | Day 3, 7, 10, 14, 28 | 
| Time to achieve normalization of oxygen saturation, post-dose |  | Day 3, 7, 10, 14, 28 | 

 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