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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05084911
• Other study ID #: SP-PA-COV-301
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2021
• Est. completion date: March 24, 2023

Study information

• Verified date: June 2023
• Source: Shin Poong Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1807
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Pyramax
Pyronaridine-Artesunate(180/60mg) tablet for 3days.
• Placebo
Placebo tablet for 3days.

Locations

Country	Name	City	State
Argentina	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
Chile	Hospital Regional Dr. Leonardo Guzman de Antofagasta	Antofagasta
Chile	Icegclinic	La Florida	Santiago
Chile	Clínica Universidad de los Andes	Las Condes	Metropolitana
Chile	Centro de Estudios Clínicos e Investigaciones Médicas - CECIM	Santiago
Chile	IntegraMédica Las Condes	Santiago
Colombia	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
Korea, Republic of	The Catholic University of Korea, Bucheon ST. Mary's Hospital	Bucheon
Korea, Republic of	Busan Medical Center	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	KyungPook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam national University Hospital	Daejeon
Korea, Republic of	Chungnam National University Sejong Hospital	Daejeon
Korea, Republic of	Gimpo Woori Hospital	Gimpo-si
Korea, Republic of	Myongji Hospital	Goyang-si
Korea, Republic of	Chonnam National University Bitgoeul Hospital	Gwangju
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	Gyeonggi-do
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Incheon Sejong Hospital	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Jeonbuk National University Hospital	Jeonju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Boramae Medical Center	Seoul
Korea, Republic of	Chosun University Hospital	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Eunpyeong St. Marys' Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Sahmyook medical Center	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Seoul Red Cross Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Yongin Severance Hospital	Yongin
Poland	Krakowskie Centrum Medyczne	Kraków
Poland	Centrum Medyczne AMED Oddzial w Lodzi	Lódz
Poland	NZOZ Le Med	Lódz
Poland	MEDICOME - Oswiecimskie Centrum Medyczne	Oswiecim
Poland	Przychodnia Lekarska Eskulap	Skierniewice
Poland	FutureMeds Warszawa Centrum	Warszawa
Poland	CMS Sp. z o.o.	Wysokie Mazowieckie
United Kingdom	Bridle Road Clinic (Liverpool)	Birkenhead
United Kingdom	Soho Road Health Centre	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Shin Poong Pharmaceutical Co. Ltd.

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Korea, Republic of,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.		follow up to Day29
Secondary	Time to sustained recovery (discharge) in hospitalized subjects (days)		follow up to Day29
Secondary	29-day mortality after the first dose of the investigational product		Day29
Secondary	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
Secondary	NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline		Day3, Day7, Day14, Day21, Day29
Secondary	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
Secondary	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
Secondary	Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14		Day2, Day3, Day5, Day7, Day14
Secondary	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