The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients (Phase3)
NCT ID: NCT05084911
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1807 participants
INTERVENTIONAL
2021-10-18
2023-03-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Test
Pyramax tablet
Pyramax
Pyronaridine-Artesunate(180/60mg) tablet for 3days.
Control
Placebo tablet
Placebo
Placebo tablet for 3days.
Interventions
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Pyramax
Pyronaridine-Artesunate(180/60mg) tablet for 3days.
Placebo
Placebo tablet for 3days.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Shin Poong Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Instituto Medico Platense
Buenos Aires, , Argentina
Ciprec - Centro de Investigación Y Prevención Cardiovascular
Caba, , Argentina
Hospital de Agudos "Dr. Ignacio Pirovano"
Caba, , Argentina
Instituto Médico Río Cuarto
Córdoba, , Argentina
Clinica Privada Independencia
Munro, , Argentina
Centro Médico IPAM
Santa Fe, , Argentina
Icegclinic
La Florida, Santiago Metropolitan, Chile
Clínica Universidad de los Andes
Las Condes, Santiago Metropolitan, Chile
Hospital Regional Dr. Leonardo Guzman de Antofagasta
Antofagasta, , Chile
Centro de Estudios Clínicos e Investigaciones Médicas - CECIM
Santiago, , Chile
IntegraMédica Las Condes
Santiago, , Chile
Clínica de la Costa Ltda
Barranquilla, , Colombia
Corazon IPS S.A.S
Barranquilla, , Colombia
IPS Centro Cientifico Asisitencial S.A.S
Barranquilla, , Colombia
Centro de Estudios e Investigación en salud-CEIS
Bogotá, , Colombia
Centro de Investigacion en Reumatología y Especialidades Médicas-CIREEM S.A.S
Bogotá, , Colombia
Fundación Valle del Lili
Cali, , Colombia
Institución Prestadora de servicios de salud Centro Medico Julian Coronel S.A.S
Cali, , Colombia
Clinica Universidad de la Sabana
Chía, , Colombia
Fundación Cardiovascular de Colombia
Floridablanca, , Colombia
Asociación IPS Médicos Internistas de Caldas S.A.S
Manizales, , Colombia
Healthy Medical Center S.A.S.
Manizales, , Colombia
Programa de Estudio y Control de Enfermedades Tropicales PECET. Universidad de Antoquia
Medellín, , Colombia
Clinisalud del Sur S.A.S
Sabaneta, , Colombia
Krakowskie Centrum Medyczne
Krakow, , Poland
Centrum Medyczne AMED Oddział w Łodzi
Lodz, , Poland
NZOZ Le Med
Lodz, , Poland
MEDICOME - Oświęcimskie Centrum Medyczne
Oświęcim, , Poland
Przychodnia Lekarska Eskulap
Skierniewice, , Poland
FutureMeds Warszawa Centrum
Warsaw, , Poland
CMS Sp. z o.o.
Wysokie Mazowieckie, , Poland
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si, , South Korea
Busan Medical Center
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
KyungPook National University Chilgok Hospital
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam national University Hospital
Daejeon, , South Korea
Chungnam National University Sejong Hospital
Daejeon, , South Korea
Gimpo Woori Hospital
Gimpo-si, , South Korea
Myongji Hospital
Goyang-si, , South Korea
Chonnam National University Bitgoeul Hospital
Gwangju, , South Korea
Gyeonggi Medical Center An-sung Hospital
Gyeonggi-do, , South Korea
Gyeonggi Medical Center Icheon Hospital
Gyeonggi-do, , South Korea
Gyeonggi Medical Center Paju Hospital
Gyeonggi-do, , South Korea
Gyeonggi Medical Center Pocheon Hospital
Gyeonggi-do, , South Korea
Gyeonggi Medical Center Suwon Hospital
Gyeonggi-do, , South Korea
Gyeonggi Medical Center Uijeongbu Hospital
Gyeonggi-do, , South Korea
Inje University Ilsan Paik Hospital
Ilsan, , South Korea
Incheon Sejong Hospital
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Boramae Medical Center
Seoul, , South Korea
Chosun University Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Eunpyeong St. Marys' Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
National Medical Center
Seoul, , South Korea
Sahmyook medical Center
Seoul, , South Korea
Seoul Medical Center
Seoul, , South Korea
Seoul Red Cross Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Yongin Severance Hospital
Yŏngin, , South Korea
Bridle Road Clinic (Liverpool)
Birkenhead, , United Kingdom
Soho Road Health Centre
Birmingham, , United Kingdom
Countries
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Other Identifiers
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SP-PA-COV-301
Identifier Type: -
Identifier Source: org_study_id
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