Clinical trial NCT05084911: The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients (Phase3)
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: Pyramax
Pyronaridine
Artesunate
COVID-19
Corona virus
Lead sponsor: Shin Poong Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 1807
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
timeFrame: follow up to Day29
Secondary outcomes:
measure: Time to sustained recovery (discharge) in hospitalized subjects (days)
timeFrame: follow up to Day29
measure: 29-day mortality after the first dose of the investigational product
timeFrame: Day29
measure: 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
timeFrame: Day3, Day7, Day14, Day21, Day29
measure: NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline
timeFrame: Day3, Day7, Day14, Day21, Day29
measure: 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
timeFrame: follow up to Day29
measure: Percentage of subjects who have newly diagnosed with pneumonia or aggravated pneumonia* according to baseline pneumonia criteria until D29 after administration of the IP
timeFrame: follow up to Day29
measure: Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14
timeFrame: Day2, Day3, Day5, Day7, Day14
measure: Percentage of subjects in the high-risk group** who require hospitalization or have died due to COVID-19 until post-dose D29
timeFrame: follow up to Day29
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Medico Platense
city: Caba
country: Argentina
facility: Ciprec - Centro de Investigación Y Prevención Cardiovascular
city: Caba
country: Argentina
facility: Hospital de Agudos "Dr. Ignacio Pirovano"
city: Córdoba
country: Argentina
facility: Instituto Médico Río Cuarto
city: Munro
country: Argentina
facility: Clinica Privada Independencia
city: Santa Fe
country: Argentina
facility: Centro Médico IPAM
city: Las Condes
country: Chile
facility: Clínica Universidad de los Andes
state: Metropolitana
city: La Florida
country: Chile
facility: Icegclinic
state: Santiago
city: Antofagasta
country: Chile
facility: Hospital Regional Dr. Leonardo Guzman de Antofagasta
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos e Investigaciones Médicas - CECIM
city: Santiago
country: Chile
facility: IntegraMédica Las Condes
city: Barranquilla
country: Colombia
facility: Clínica de la Costa Ltda
city: Barranquilla
country: Colombia
facility: Corazon IPS S.A.S
city: Barranquilla
country: Colombia
facility: IPS Centro Cientifico Asisitencial S.A.S
city: Bogotá
country: Colombia
facility: Centro de Estudios e Investigación en salud-CEIS
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatología y Especialidades Médicas-CIREEM S.A.S
city: Cali
country: Colombia
facility: Fundación Valle del Lili
city: Cali
country: Colombia
facility: Institución Prestadora de servicios de salud Centro Medico Julian Coronel S.A.S
city: Chía
country: Colombia
facility: Clinica Universidad de la Sabana
city: Floridablanca
country: Colombia
facility: Fundación Cardiovascular de Colombia
city: Manizales
country: Colombia
facility: Asociación IPS Médicos Internistas de Caldas S.A.S
city: Manizales
country: Colombia
facility: Healthy Medical Center S.A.S.
city: Medellín
country: Colombia
facility: Programa de Estudio y Control de Enfermedades Tropicales PECET. Universidad de Antoquia
city: Sabaneta
country: Colombia
facility: Clinisalud del Sur S.A.S
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon ST. Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Busan Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: KyungPook National University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam national University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
city: Gimpo-si
country: Korea, Republic of
facility: Gimpo Woori Hospital
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Bitgoeul Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi Medical Center An-sung Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi Medical Center Icheon Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi Medical Center Paju Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi Medical Center Pocheon Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi Medical Center Suwon Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi Medical Center Uijeongbu Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Incheon Sejong Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Chosun University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Marys' Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Sahmyook medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Red Cross Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
city: Oświęcim
country: Poland
facility: MEDICOME - Oświęcimskie Centrum Medyczne
city: Skierniewice
country: Poland
facility: Przychodnia Lekarska Eskulap
city: Warszawa
country: Poland
facility: FutureMeds Warszawa Centrum
city: Wysokie Mazowieckie
country: Poland
facility: CMS Sp. z o.o.
city: Łódź
country: Poland
facility: Centrum Medyczne AMED Oddział w Łodzi
city: Łódź
country: Poland
facility: NZOZ Le Med
city: Birkenhead
country: United Kingdom
facility: Bridle Road Clinic (Liverpool)
city: Birmingham
country: United Kingdom
facility: Soho Road Health Centre
Study officials:
References: