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

NCT05084911 | Completed Phase 3

• 1 other identifier: SP-PA-COV-301
• Study Type: interventional
• Target: 1,807
• Locations: 6 countries
• Sites: 66

Brief Summary

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.

Conditions

COVID-19

Keywords

Pyramax; Pyronaridine; Artesunate; COVID-19; Corona virus

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.

  follow up to Day29

Secondary Outcomes (8)

• 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

Study Arms (2)

Test

EXPERIMENTAL

Pyramax tablet

Drug: Pyramax

Control

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

Pyramax DRUG

Pyronaridine-Artesunate(180/60mg) tablet for 3days.

Test

Placebo DRUG

Placebo tablet for 3days.

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with severe or critical\* COVID-19
• 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.
• 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).
• Patients with one or more of the following infections in the past or present
• Infection with need for systemic anti-infection treatment other than Corona virus (SARS-CoV-2)
• Major infection with need for oral antibiotics or hospitalization within 30 days before administration of the investigational product by discretion of the investigator.
• Patients with a known clinically significant anemia (Hemoglobin \<8.0 g/dL)
• Patients with a known severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2)
• Patients with a known severe hepatic dysfunction
• Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of the 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 with the Investigational Product
• Pregnant, breast-feeding or females with positive pregnancy test at screening
• 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
• Patients who have participated in another clinical study/device study and received the investigational product/device within 28 days from signing the informed consent

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (66)

Instituto Medico Platense

Buenos Aires, Argentina

Location

Ciprec - Centro de Investigación Y Prevención Cardiovascular

Caba, Argentina

Location

Hospital de Agudos "Dr. Ignacio Pirovano"

Caba, Argentina

Location

Instituto Médico Río Cuarto

Córdoba, Argentina

Location

Clinica Privada Independencia

Munro, Argentina

Location

Centro Médico IPAM

Santa Fe, Argentina

Location

Icegclinic

La Florida, Santiago Metropolitan, piso 4, Chile

Location

Clínica Universidad de los Andes

Las Condes, Santiago Metropolitan, Chile

Location

Hospital Regional Dr. Leonardo Guzman de Antofagasta

Antofagasta, Chile

Location

Centro de Estudios Clínicos e Investigaciones Médicas - CECIM

Santiago, Chile

Location

IntegraMédica Las Condes

Santiago, Chile

Location

Clínica de la Costa Ltda

Barranquilla, Colombia

Location

Corazon IPS S.A.S

Barranquilla, Colombia

Location

IPS Centro Cientifico Asisitencial S.A.S

Barranquilla, Colombia

Location

Centro de Estudios e Investigación en salud-CEIS

Bogotá, carrera 7, Colombia

Location

Centro de Investigacion en Reumatología y Especialidades Médicas-CIREEM S.A.S

Bogotá, Colombia

Location

Fundación Valle del Lili

Cali, Colombia

Location

Institución Prestadora de servicios de salud Centro Medico Julian Coronel S.A.S

Cali, Colombia

Location

Clinica Universidad de la Sabana

Chía, Colombia

Location

Fundación Cardiovascular de Colombia

Floridablanca, Colombia

Location

Asociación IPS Médicos Internistas de Caldas S.A.S

Manizales, Colombia

Location

Healthy Medical Center S.A.S.

Manizales, Colombia

Location

Programa de Estudio y Control de Enfermedades Tropicales PECET. Universidad de Antoquia

Medellín, Colombia

Location

Clinisalud del Sur S.A.S

Sabaneta, Colombia

Location

Krakowskie Centrum Medyczne

Krakow, Poland

Location

Centrum Medyczne AMED Oddział w Łodzi

Lodz, Poland

Location

NZOZ Le Med

Lodz, Poland

Location

MEDICOME - Oświęcimskie Centrum Medyczne

Oświęcim, Poland

Location

Przychodnia Lekarska Eskulap

Skierniewice, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, Poland

Location

CMS Sp. z o.o.

Wysokie Mazowieckie, Poland

Location

The Catholic University of Korea, Bucheon ST. Mary's Hospital

Bucheon-si, South Korea

Location

Busan Medical Center

Busan, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

KyungPook National University Chilgok Hospital

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chungnam national University Hospital

Daejeon, South Korea

Location

Chungnam National University Sejong Hospital

Daejeon, South Korea

Location

Gimpo Woori Hospital

Gimpo-si, South Korea

Location

Myongji Hospital

Goyang-si, South Korea

Location

Chonnam National University Bitgoeul Hospital

Gwangju, South Korea

Location

Gyeonggi Medical Center An-sung Hospital

Gyeonggi-do, South Korea

Location

Gyeonggi Medical Center Icheon Hospital

Gyeonggi-do, South Korea

Location

Gyeonggi Medical Center Paju Hospital

Gyeonggi-do, South Korea

Location

Gyeonggi Medical Center Pocheon Hospital

Gyeonggi-do, South Korea

Location

Gyeonggi Medical Center Suwon Hospital

Gyeonggi-do, South Korea

Location

Gyeonggi Medical Center Uijeongbu Hospital

Gyeonggi-do, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Location

Incheon Sejong Hospital

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Boramae Medical Center

Seoul, South Korea

Location

Chosun University Hospital

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Eunpyeong St. Marys' Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, South Korea

Location

National Medical Center

Seoul, South Korea

Location

Sahmyook medical Center

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

Seoul Red Cross Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Yongin Severance Hospital

Yŏngin, South Korea

Location

Bridle Road Clinic (Liverpool)

Birkenhead, United Kingdom

Location

Soho Road Health Centre

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

pyronaridine tetraphosphate, artesunate drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 20, 2021
• Study Start: October 18, 2021
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

PL (7); CL (5); KR (33); CO (13); GB (2); AR (6)