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

• Sponsor: Shin Poong Pharmaceutical Co. Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05084911
• Collaborator: (none)
• Enrollment: 1,420
• Locations: 70
• Arms: 2
• Anticipated Duration (Months): 13.4
• Patients Per Site: 20.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Pyramax; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 18, 2021
• Anticipated Primary Completion Date: Oct 30, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Time to sustained recovery (discharge) in hospitalized subjects (days) [follow up to Day29]

2. 29-day mortality after the first dose of the investigational product [Day29]

3. 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]

4. NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline [Day3, Day7, Day14, Day21, Day29]

5. 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]

6. 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]

7. Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14 [Day2, Day3, Day5, Day7, Day14]

8. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

5. Infection with need for systemic anti-infection treatment other than Corona virus (SARS-CoV-2)

6. Major infection with need for oral antibiotics or hospitalization within 30 days before administration of the investigational product by discretion of the investigator.

7. Patients with a known clinically significant anemia (Hemoglobin <8.0 g/dL)

8. Patients with a known severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2)

9. Patients with a known severe hepatic dysfunction

10. Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of the investigational product

11. 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)

12. Patients who cannot be orally administered with the Investigational Product

13. Pregnant, breast-feeding or females with positive pregnancy test at screening

14. 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

15. Patients who have participated in another clinical study/device study and received the investigational product/device within 28 days from signing the informed consent

16. 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

17. Patients with history of alcohol or drug abuse within 12 months before administration of the investigational product

18. Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Investigaciones Clínicas Quilmes S.R.L.	Buenos Aires		Argentina
2	Instituto Medico Platense	Buenos Aires		Argentina
3	Sanatorio Sagrado Corazon	Buenos Aires		Argentina
4	Ciprec - Centro de Investigación Y Prevención Cardiovascular	Caba		Argentina
5	Hospital de Agudos "Dr. Ignacio Pirovano"	Caba		Argentina
6	Instituto Médico Río Cuarto	Córdoba		Argentina
7	Clinica Privada Independencia	Munro		Argentina
8	Centro Médico IPAM	Santa Fe		Argentina
9	Instituto Medico Catamarca IMEC	Santa Fe		Argentina
10	Hospital Regional Dr. Leonardo Guzman de Antofagasta	Antofagasta		Chile
11	Centro de Estudios Clínicos e Investigaciones Médicas - CECIM	Santiago		Chile
12	IntegraMédica Las Condes	Santiago		Chile
13	RedSalud Santiago	Santiago		Chile
14	Centro de Investigación del Maule SPA	Talca		Chile
15	Clínica de la Costa Ltda	Barranquilla		Colombia
16	Corazon IPS S.A.S	Barranquilla		Colombia
17	IPS Centro Cientifico Asisitencial S.A.S	Barranquilla		Colombia
18	Centro de Investigacion en Reumatología y Especialidades Médicas-CIREEM S.A.S	Bogotá		Colombia
19	Institución Prestadora de Servicios de Salud Clinica de la Mujer S.A.S	Bogotá		Colombia
20	Fundación Valle del Lili	Cali		Colombia
21	Institución Prestadora de servicios de salud Centro Medico Julian Coronel S.A.S	Cali		Colombia
22	Clinica Universidad de la Sabana	Chía		Colombia
23	Fundación Cardiovascular de Colombia	Floridablanca		Colombia
24	Asociación IPS Médicos Internistas de Caldas S.A.S	Manizales		Colombia
25	Healthy Medical Center S.A.S.	Manizales		Colombia
26	Programa de Estudio y Control de Enfermedades Tropicales PECET. Universidad de Antoquia	Medellín		Colombia
27	Clinisalud del Sur S.A.S	Sabaneta		Colombia
28	The Catholic University of Korea, Bucheon ST. Mary's Hospital	Bucheon		Korea, Republic of
29	Busan Medical Center	Busan		Korea, Republic of
30	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
31	KyungPook National University Chilgok Hospital	Daegu		Korea, Republic of
32	Kyungpook National University Hospital	Daegu		Korea, Republic of
33	Chungnam national University Hospital	Daejeon		Korea, Republic of
34	Chungnam National University Sejong Hospital	Daejeon		Korea, Republic of
35	Gimpo Woori Hospital	Gimpo-si		Korea, Republic of
36	Myongji Hospital	Goyang-si		Korea, Republic of
37	Chonnam National University Bitgoeul Hospital	Gwangju		Korea, Republic of
38	Gyeonggi Medical Center An-sung Hospital	Gyeonggi-do		Korea, Republic of
39	Gyeonggi Medical Center Icheon Hospital	Gyeonggi-do		Korea, Republic of
40	Gyeonggi Medical Center Paju Hospital	Gyeonggi-do		Korea, Republic of
41	Gyeonggi Medical Center Pocheon Hospital	Gyeonggi-do		Korea, Republic of
42	Gyeonggi Medical Center Suwon Hospital	Gyeonggi-do		Korea, Republic of
43	Gyeonggi Medical Center Uijeongbu Hospital	Gyeonggi-do		Korea, Republic of
44	Inje University Ilsan Paik Hospital	Ilsan		Korea, Republic of
45	Incheon Sejong Hospital	Incheon		Korea, Republic of
46	Inha University Hospital	Incheon		Korea, Republic of
47	Jeonbuk National University Hospital	Jeonju		Korea, Republic of
48	Pusan National University Hospital	Pusan		Korea, Republic of
49	Boramae Medical Center	Seoul		Korea, Republic of
50	Chosun University Hospital	Seoul		Korea, Republic of
51	Chung-Ang University Hospital	Seoul		Korea, Republic of
52	Eunpyeong St. Marys' Hospital	Seoul		Korea, Republic of
53	Korea University Guro Hospital	Seoul		Korea, Republic of
54	Kyung Hee University Medical Center	Seoul		Korea, Republic of
55	National Medical Center	Seoul		Korea, Republic of
56	Sahmyook medical Center	Seoul		Korea, Republic of
57	Seoul Medical Center	Seoul		Korea, Republic of
58	Seoul Red Cross Hospital	Seoul		Korea, Republic of
59	Ajou University Hospital	Suwon		Korea, Republic of
60	Yongin Severance Hospital	Yongin		Korea, Republic of
61	Krakowskie Centrum Medyczne	Kraków		Poland
62	MEDICOME - Oświęcimskie Centrum Medyczne	Oświęcim		Poland
63	Przychodnia Lekarska Eskulap	Skierniewice		Poland
64	FutureMeds Warszawa Centrum	Warszawa		Poland
65	CMS Sp. z o.o.	Wysokie Mazowieckie		Poland
66	Centrum Medyczne AMED Oddział w Łodzi	Łódź		Poland
67	Miejskie Centrum Medyczne Widzew w Łodzi	Łódź		Poland
68	NZOZ Le Med	Łódź		Poland
69	Bridle Road Clinic (Liverpool)	Birkenhead		United Kingdom
70	Soho Road Health Centre	Birmingham		United Kingdom

Sponsors and Collaborators

• Shin Poong Pharmaceutical Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shin Poong Pharmaceutical Co. Ltd.
• ClinicalTrials.gov Identifier: NCT05084911
• Other Study ID Numbers: SP-PA-COV-301
• First Posted: Oct 20, 2021
• Last Update Posted: Jun 28, 2022
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shin Poong Pharmaceutical Co. Ltd.: Pyramax; Pyronaridine; Artesunate; COVID-19; Corona virus
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jun 28, 2022