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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Pyramax; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1807
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ji-Woong Ryu; Phone Number: spnct@shinpoong.co.kr; Email: spnct@shinpoong.co.kr

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Instituto Medico Platense
  • Caba, Argentina
    • CIPREC - Centro de Investigación y Prevención Cardiovascular
  • Caba, Argentina
    • Hospital de Agudos "Dr. Ignacio Pirovano"
  • Córdoba, Argentina
    • Instituto Médico Río Cuarto
  • Munro, Argentina
    • Clínica Privada Independencia
  • Santa Fe, Argentina
    • Centro Medico IPAM
• Chile
  • Antofagasta, Chile
    • Hospital Regional Dr. Leonardo Guzman de Antofagasta
  • Santiago, Chile
    • Centro de Estudios Clínicos e Investigaciones Médicas - CECIM
  • Santiago, Chile
    • IntegraMédica Las Condes
  • Metropolitana
    • Las Condes, Metropolitana, Chile
      • Clínica Universidad de los Andes
  • Santiago
    • La Florida, Santiago, Chile, piso 4
      • Icegclinic
• Colombia
  • Barranquilla, Colombia
    • Clinica de la Costa Ltda
  • Barranquilla, Colombia
    • Corazón IPS S.A.S
  • Barranquilla, Colombia
    • IPS Centro Cientifico Asisitencial S.A.S
  • Bogotá, Colombia, carrera 7
    • Centro de Estudios e Investigación en salud-CEIS
  • Bogotá, Colombia
    • Centro de Investigacion en Reumatología y Especialidades Médicas-CIREEM S.A.S
  • Cali, Colombia
    • Fundacion Valle del Lili
  • Cali, Colombia
    • Institución Prestadora de servicios de salud Centro Medico Julian Coronel S.A.S
  • Chía, Colombia
    • Clínica Universidad de la sabana
  • Floridablanca, Colombia
    • Fundación Cardiovascular de Colombia
  • Manizales, Colombia
    • Asociación IPS Médicos Internistas de Caldas S.A.S
  • Manizales, Colombia
    • Healthy Medical Center S.A.S.
  • Medellín, Colombia
    • Programa de Estudio y Control de Enfermedades Tropicales PECET. Universidad de Antoquia
  • Sabaneta, Colombia
    • Clinisalud del Sur S.A.S
• Korea, Republic of
  • Bucheon, Korea, Republic of
    • The Catholic University of Korea, Bucheon St. Mary's Hospital
  • Busan, Korea, Republic of
    • Busan Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Kyungpook National University Chilgok Hospital
  • Daejeon, Korea, Republic of
    • Chungnam national university hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Sejong Hospital
  • Gimpo-si, Korea, Republic of
    • Gimpo Woori Hospital
  • Goyang-si, Korea, Republic of
    • Myongji Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Bitgoeul Hospital
  • Gyeonggi-do, Korea, Republic of
    • Gyeonggi Medical Center An-sung Hospital
  • Gyeonggi-do, Korea, Republic of
    • Gyeonggi Medical Center Icheon Hospital
  • Gyeonggi-do, Korea, Republic of
    • Gyeonggi Medical Center Paju Hospital
  • Gyeonggi-do, Korea, Republic of
    • Gyeonggi Medical Center Pocheon Hospital
  • Gyeonggi-do, Korea, Republic of
    • Gyeonggi Medical Center Suwon Hospital
  • Gyeonggi-do, Korea, Republic of
    • Gyeonggi Medical Center Uijeongbu Hospital
  • Ilsan, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Incheon Sejong Hospital
  • Jeonju, Korea, Republic of
    • Jeonbuk National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • National Medical Center
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Seoul Medical Center
  • Seoul, Korea, Republic of
    • Boramae Medical Center
  • Seoul, Korea, Republic of
    • Sahmyook medical Center
  • Seoul, Korea, Republic of
    • Chosun university hospital
  • Seoul, Korea, Republic of
    • Eunpyeong St. Marys' Hospital
  • Seoul, Korea, Republic of
    • Seoul Red Cross Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Yongin, Korea, Republic of
    • Yongin Severance Hospital
• Poland
  • Kraków, Poland
    • Krakowskie Centrum Medyczne
  • Oświęcim, Poland
    • MEDICOME - Oświęcimskie Centrum Medyczne
  • Skierniewice, Poland
    • Przychodnia Lekarska Eskulap
  • Warszawa, Poland
    • FutureMeds Warszawa Centrum
  • Wysokie Mazowieckie, Poland
    • CMS Sp. z o.o.
  • Łódź, Poland
    • Centrum Medyczne AMED oddział w Łodzi
  • Łódź, Poland
    • NZOZ Le Med
• United Kingdom
  • Birkenhead, United Kingdom
    • Bridle Road Clinic (Liverpool)
  • Birmingham, United Kingdom
    • Soho Road Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult males and females aged 19 years or older (or minimum age for adulthood or for informed consent below 19 years for each country)
2. Patients with body weight ≥45 kg at screening
3. Patients with COVID-19 confirmed by RT-PCR before randomization
4. 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
5. 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:

1. Patients with severe or critical* COVID-19
2. 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.
3. 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).

4. Patients with one or more of the following infections in the past or present

   1. Infection with need for systemic anti-infection treatment other than Corona virus (SARS-CoV-2)
   2. Major infection with need for oral antibiotics or hospitalization within 30 days before administration of the investigational product by discretion of the investigator.
5. Patients with a known clinically significant anemia (Hemoglobin <8.0 g/dL)
6. Patients with a known severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2)
7. Patients with a known severe hepatic dysfunction
8. Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of the investigational product
9. 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)
10. Patients who cannot be orally administered with the Investigational Product
11. Pregnant, breast-feeding or females with positive pregnancy test at screening
12. 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
13. Patients who have participated in another clinical study/device study and received the investigational product/device within 28 days from signing the informed consent
14. 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
15. Patients with history of alcohol or drug abuse within 12 months before administration of the investigational product
16. Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Artesunate; Pyramax; Corona virus; Pyronaridine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Pyronaridine tetraphosphate, artesunate drug combination
• Other Study ID Numbers: SP-PA-COV-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No