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

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ClinicalTrials.gov Identifier: NCT04475107
Recruitment Status : Completed
First Posted : July 17, 2020
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Shin Poong Pharmaceutical Co. Ltd.

Brief Summary:
This study is 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Pyronaridine-Artesunate Drug: Placebo Phase 2

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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)
Drug: Pyronaridine-Artesunate
Pyramax

Placebo Comparator: Arm B
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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

  3. 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 ]
  4. 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 ]
  5. Time to achieve normalization of body temperature, post-dose [ Time Frame: Day 3, 7, 10, 14, 28 ]
  6. Time to achieve normalization of respiratory rate, post-dose [ Time Frame: Day 3, 7, 10, 14, 28 ]
  7. Time to achieve normalization of oxygen saturation, post-dose [ Time Frame: Day 3, 7, 10, 14, 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥19 years at the time of signing Informed Consent Form
  2. Body weight ≥45 kg at screening
  3. 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
  4. Oxygen saturation(SpO2) > 94% at randomization, in room air condition
  5. Willing and able to provide informed consent

Exclusion Criteria:

  1. Diagnosed with severe pneumonia
  2. Patients with clinically significant cardiovascular disease (including arrhythmia, QTc interval prolongation)
  3. Patients with clinically significant anemia (Hemoglobin <8.0 g/dL)
  4. Patient with known allergic reaction or contraindication to any of the investigational medicinal product (pyronaridine tetraphosphate, artesunate)
  5. Patients with known history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
  6. 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)
  7. 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)
  8. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
  9. 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)
  10. Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of other antiviral agents
  11. Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc.)
  12. 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.
  13. Pregnant or lactating women
  14. 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.)

  15. Participating in another clinical trial currently or within 28 days from signing the informed consent
  16. Patients that are deemed ineligible to participate in the clinical trial by the Investigator

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Shin Poong Pharmaceutical Co. Ltd.
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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

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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:
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Artesunate
Pyronaridine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics