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

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Recruiting
participants needed

76
sponsor

Shin Poong Pharmaceutical Co. Ltd.

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Updated on 19 February 2024

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oximetry

covid-19

SARS

oropharyngeal

acute respiratory syndrome (sars)

Summary

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

Details

Condition	Covid 19
Age	19-100 years
Treatment	Placebo, Pyronaridine-Artesunate
Clinical Study Identifier	NCT04475107
Sponsor	Shin Poong Pharmaceutical Co. Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 72 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

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Step 4 Get your study results

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