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

June 16, 2023 updated by: Shin Poong Pharmaceutical Co. Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1807

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Instituto Medico Platense
      • Caba, Argentina
        • Ciprec - Centro de Investigacion y Prevencion Cardiovascular
      • Caba, Argentina
        • Hospital de Agudos "Dr. Ignacio Pirovano"
      • Córdoba, Argentina
        • Instituto Médico Río Cuarto
      • Munro, Argentina
        • Clinica Privada Independencia
      • Santa Fe, Argentina
        • Centro Medico IPAM
  • Chile
      • Antofagasta, Chile
        • Hospital Regional Dr. Leonardo Guzmán de Antofagasta
      • Santiago, Chile
        • Centro de Estudios Clínicos e Investigaciones Médicas - CECIM
      • Santiago, Chile
        • IntegraMédica Las Condes
    • Metropolitana
      • Las Condes, Metropolitana, Chile
        • Clinica Universidad de Los Andes
    • Santiago
      • La Florida, Santiago, Chile, piso 4
        • Icegclinic
  • Colombia
      • Barranquilla, Colombia
        • Clinica de la Costa Ltda
      • Barranquilla, Colombia
        • Corazón IPS S.A.S
      • Barranquilla, Colombia
        • IPS Centro Cientifico Asisitencial S.A.S
      • Bogotá, Colombia, carrera 7
        • Centro de Estudios e Investigación en salud-CEIS
      • Bogotá, Colombia
        • Centro de Investigacion en Reumatología y Especialidades Médicas-CIREEM S.A.S
      • Cali, Colombia
        • Fundación Valle Del Lili
      • Cali, Colombia
        • Institución Prestadora de servicios de salud Centro Medico Julian Coronel S.A.S
      • Chía, Colombia
        • Clínica Universidad De la Sabana
      • Floridablanca, Colombia
        • Fundacion cardiovascular de Colombia
      • Manizales, Colombia
        • Asociación IPS Médicos Internistas de Caldas S.A.S
      • Manizales, Colombia
        • Healthy Medical Center S.A.S.
      • Medellín, Colombia
        • Programa de Estudio y Control de Enfermedades Tropicales PECET. Universidad de Antoquia
      • Sabaneta, Colombia
        • Clinisalud del Sur S.A.S
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
      • Busan, Korea, Republic of
        • Busan Medical Center
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of
        • Kyungpook National University Chilgok Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Sejong Hospital
      • Gimpo-si, Korea, Republic of
        • Gimpo Woori Hospital
      • Goyang-si, Korea, Republic of
        • MyongJi Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Bitgoeul Hospital
      • Gyeonggi-do, 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
      • Ilsan, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Incheon Sejong Hospital
      • Jeonju, Korea, Republic of
        • Jeonbuk National University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Seoul, Korea, Republic of
        • Kyung Hee University Medical Center
      • Seoul, Korea, Republic of
        • National Medical Center
      • Seoul, Korea, Republic of
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Seoul Medical Center
      • Seoul, Korea, Republic of
        • Boramae Medical Center
      • Seoul, Korea, Republic of
        • Sahmyook medical Center
      • Seoul, Korea, Republic of
        • Chosun University Hospital
      • Seoul, Korea, Republic of
        • Eunpyeong St. Marys' Hospital
      • Seoul, Korea, Republic of
        • Seoul Red Cross Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Yongin, Korea, Republic of
        • Yongin Severance Hospital
  • Poland
      • Kraków, Poland
        • Krakowskie Centrum Medyczne
      • Oświęcim, Poland
        • MEDICOME - Oświęcimskie Centrum Medyczne
      • Skierniewice, Poland
        • Przychodnia Lekarska Eskulap
      • Warszawa, Poland
        • FutureMeds Warszawa Centrum
      • Wysokie Mazowieckie, Poland
        • CMS Sp. z o.o.
      • Łódź, Poland
        • Centrum Medyczne AMED oddział w Łodzi
      • Łódź, Poland
        • NZOZ Le Med
  • United Kingdom
      • Birkenhead, United Kingdom
        • Bridle Road Clinic (Liverpool)
      • Birmingham, United Kingdom
        • Soho Road Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test
Pyramax tablet
Drug: Pyramax
Pyronaridine-Artesunate(180/60mg) tablet for 3days.
Placebo Comparator: Control
Placebo tablet
Drug: Placebo
Placebo tablet for 3days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
Time Frame: follow up to Day29
follow up to Day29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to sustained recovery (discharge) in hospitalized subjects (days)
Time Frame: follow up to Day29
follow up to Day29
29-day mortality after the first dose of the investigational product
Time Frame: Day29
Day29
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
Time Frame: Day3, Day7, Day14, Day21, Day29
Day3, Day7, Day14, Day21, Day29
NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline
Time Frame: Day3, Day7, Day14, Day21, Day29
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
Time Frame: follow up to Day29
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
Time Frame: follow up to Day29
follow up to Day29
Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14
Time Frame: Day2, Day3, Day5, Day7, Day14
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
Time Frame: follow up to Day29
follow up to Day29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shin Poong Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP-PA-COV-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings