The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04475107 |
Recruitment Status :
Completed
First Posted : July 17, 2020
Last Update Posted : June 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Pyronaridine-Artesunate Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 113 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 Ⅱ Clinical Trial to Evaluate Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients |
Actual Study Start Date : | July 9, 2020 |
Actual Primary Completion Date : | March 25, 2021 |
Actual Study Completion Date : | April 15, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
Pyramax (Pyronaridine 180mg/ Artesunate 60mg)
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Drug: Pyronaridine-Artesunate
Pyramax |
Placebo Comparator: Arm B
Placebo
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Drug: Placebo
Placebo |
- Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose* [ Time Frame: Day 7 ]* Patients who are rRT-PCR negative for COVID-19
- Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline [ Time Frame: Day 3, 7, 10, 14 ]
- Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose* [ Time Frame: Day 3, 10, 14 ]* Patients who are rRT-PCR negative for COVID-19
- Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline [ Time Frame: Day 3, 7, 10, 14, 28 ]
- Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline [ Time Frame: Day 3, 7, 10, 14, 28 ]
- Time to achieve normalization of body temperature, post-dose [ Time Frame: Day 3, 7, 10, 14, 28 ]
- Time to achieve normalization of respiratory rate, post-dose [ Time Frame: Day 3, 7, 10, 14, 28 ]
- Time to achieve normalization of oxygen saturation, post-dose [ Time Frame: Day 3, 7, 10, 14, 28 ]

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥19 years at the time of signing Informed Consent Form
- Body weight ≥45 kg at screening
- Laboratory (rRT-PCR) confirmed infection with SARS-CoV-2 by testing specimens from upper airway (i.e. nasopharyngeal and oropharyngeal swab) or lower airway (i.e. sputum) within 96 hours of randomization
- Oxygen saturation(SpO2) > 94% at randomization, in room air condition
- Willing and able to provide informed consent
Exclusion Criteria:
- Diagnosed with severe pneumonia
- Patients with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation)
- Patients with clinically significant anemia (Hemoglobin <8.0 g/dL)
- Patient with known allergic reaction or contraindication to any of the investigational medicinal product (pyronaridine tetraphosphate, artesunate)
- Patients with known history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
- Patients with the gastrointestinal disease and surgery to affect the absorption, distribution, metabolism and excretion of the drug, active gastritis, gastrointestinal tract / rectal bleeding, gastric ulcer, pancreatitis abnormalities (except simple appendectomy or hernia surgery)
- Patients who received antiviral drugs that is intended to treat COVID-19, within 28 days prior to screening evaluation (can be enrolled into the study, if the patient has gone through a sufficient wash-out period)
- Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
- Patients with known severe liver disease (i.e. ALT or AST>5 times upper limit, nausea, abdominal pain associated with jaundice or Child-Pugh stage B or C)
- Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of other antiviral agents
- Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.)
- Patients with chronic underlying disease (e.g. uncontrolled diabetes mellitus, chronic kidney disease, chronic liver disease, chronic pulmonary disease, chronic cardiovascular disease, blood cancer, cancer patients with cancer treatment, patients taking immunosuppressants), highly obese patients, dialysis patients, and transplant patients that are determined by the Physician, to be not suitable for trial involvement.
- Pregnant or lactating women
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Male or female of childbearing potential who has plans to become pregnant during the study period and for three months after the clinical study or who is not willing to take appropriate contraceptive measures
*Hormonal contraception (contraceptive implant, injections, pills, etc.), IUDs, condoms (male) and contraceptive diaphragm or cap (female), sterilization (vasectomy, tubal ligation, etc.)
- Participating in another clinical trial currently or within 28 days from signing the informed consent
- Patients that are deemed ineligible to participate in the clinical trial by the Investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475107
Korea, Republic of | |
Korea University Ansan Hospital | |
Ansan, Korea, Republic of | |
Chungnam national University Hospital | |
Daejeon, Korea, Republic of | |
Inha University Hospital | |
Incheon, Korea, Republic of | |
Gangnam Severance Hospital | |
Seoul, Korea, Republic of | |
Hallym University Kangnam Sacred Heart Hospital | |
Seoul, Korea, Republic of | |
Korea University Guro Hospital | |
Seoul, Korea, Republic of | |
Kyungpook National University Hospital | |
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 | |
Severance Hospital | |
Seoul, Korea, Republic of | |
The Catholic University of Korea, Eunpyeong St. Marys' Hospital | |
Seoul, Korea, Republic of | |
Ajou University Hospital | |
Suwon, Korea, Republic of |
Responsible Party: | Shin Poong Pharmaceutical Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT04475107 |
Other Study ID Numbers: |
SP-PA-COV-201 |
First Posted: | July 17, 2020 Key Record Dates |
Last Update Posted: | June 1, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pyramax Pyronaridine Artesunate COVID-19 Corona virus |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Artesunate Pyronaridine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics |