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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Pyramax tablet |
|
| Control | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyramax | Drug | Pyronaridine-Artesunate(180/60mg) tablet for 3days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29. | follow up to Day29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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
Patients with history of alcohol or drug abuse within 12 months before administration of the investigational product
Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Medico Platense | Buenos Aires | Argentina | ||||
| Ciprec - Centro de Investigación Y Prevención Cardiovascular |
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| Placebo |
| Drug |
Placebo tablet for 3days. |
|
| 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 |
| 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 |
| Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14 | Day2, Day3, Day5, Day7, Day14 |
| 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 |
| 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 | piso 4 | 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 | carrera 7 | 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 | Yongin | South Korea |
| Bridle Road Clinic (Liverpool) | Birkenhead | United Kingdom |
| Soho Road Health Centre | Birmingham | United Kingdom |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000712628 | pyronaridine tetraphosphate, artesunate drug combination |
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