COVID-19Phase 3NCT05084911
The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients (Phase3)
A Phase 3 study testing Pyramax in people with COVID-19, run by Shin Poong Pharmaceutical Co. Ltd. at 66 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Pyramax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,807 participants
- Where
- 66 sitesin 6 countries
- Study dates
- 18 Oct 2021to 24 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged 19 years or older (or minimum age for adulthood or for informed consent below 19 years for each country)
- Patients with body weight ≥45 kg at screening
- Patients with COVID-19 confirmed by RT-PCR before randomization
- 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
- 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
Who cannot join
- 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
- Infection with need for systemic anti-infection treatment other than Corona virus (SARS-CoV-2)
- Major infection with need for oral antibiotics or hospitalization within 30 days before administration of the investigational product by discretion of the investigator.
Show all 18Show fewer
- 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
Trial locations and contacts
66 sites in 6 countries.
66 sites in 6 countries
South Korea33 sites
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si
Busan Medical Center
Busan
Keimyung University Dongsan Medical Center
Daegu
KyungPook National University Chilgok Hospital
Daegu
Kyungpook National University Hospital
Daegu
Chungnam national University Hospital
Daejeon
Chungnam National University Sejong Hospital
Daejeon
Gimpo Woori Hospital
Gimpo-si
Myongji Hospital
Goyang-si
Chonnam National University Bitgoeul Hospital
Gwangju
Gyeonggi Medical Center An-sung Hospital
Gyeonggi-do
Gyeonggi Medical Center Icheon Hospital
Gyeonggi-do
Gyeonggi Medical Center Paju Hospital
Gyeonggi-do
Gyeonggi Medical Center Pocheon Hospital
Gyeonggi-do
Gyeonggi Medical Center Suwon Hospital
Gyeonggi-do
Gyeonggi Medical Center Uijeongbu Hospital
Gyeonggi-do
Inje University Ilsan Paik Hospital
Ilsan
Incheon Sejong Hospital
Incheon
Inha University Hospital
Incheon
Jeonbuk National University Hospital
Jeonju
Pusan National University Hospital
Pusan
Boramae Medical Center
Seoul
Chosun University Hospital
Seoul
Chung-Ang University Hospital
Seoul
Eunpyeong St. Marys' Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung Hee University Medical Center
Seoul
National Medical Center
Seoul
Sahmyook medical Center
Seoul
Seoul Medical Center
Seoul
Seoul Red Cross Hospital
Seoul
Ajou University Hospital
Suwon
Yongin Severance Hospital
Yŏngin
Colombia13 sites
Clínica de la Costa Ltda
Barranquilla
Corazon IPS S.A.S
Barranquilla
IPS Centro Cientifico Asisitencial S.A.S
Barranquilla
Centro de Estudios e Investigación en salud-CEIS
Bogotá, carrera 7
Centro de Investigacion en Reumatología y Especialidades Médicas-CIREEM S.A.S
Bogotá
Fundación Valle del Lili
Cali
Institución Prestadora de servicios de salud Centro Medico Julian Coronel S.A.S
Cali
Clinica Universidad de la Sabana
Chía
Fundación Cardiovascular de Colombia
Floridablanca
Asociación IPS Médicos Internistas de Caldas S.A.S
Manizales
Healthy Medical Center S.A.S.
Manizales
Programa de Estudio y Control de Enfermedades Tropicales PECET. Universidad de Antoquia
Medellín
Clinisalud del Sur S.A.S
Sabaneta
Poland7 sites
Krakowskie Centrum Medyczne
Krakow
Centrum Medyczne AMED Oddział w Łodzi
Lodz
NZOZ Le Med
Lodz
MEDICOME - Oświęcimskie Centrum Medyczne
Oświęcim
Przychodnia Lekarska Eskulap
Skierniewice
FutureMeds Warszawa Centrum
Warsaw
CMS Sp. z o.o.
Wysokie Mazowieckie
Argentina6 sites
Instituto Medico Platense
Buenos Aires
Ciprec - Centro de Investigación Y Prevención Cardiovascular
Caba
Hospital de Agudos "Dr. Ignacio Pirovano"
Caba
Instituto Médico Río Cuarto
Córdoba
Clinica Privada Independencia
Munro
Centro Médico IPAM
Santa Fe
Chile5 sites
Hospital Regional Dr. Leonardo Guzman de Antofagasta
Antofagasta
Icegclinic
La Florida, Santiago Metropolitan, piso 4
Clínica Universidad de los Andes
Las Condes, Santiago Metropolitan
Centro de Estudios Clínicos e Investigaciones Médicas - CECIM
Santiago
IntegraMédica Las Condes
Santiago
United Kingdom2 sites
Bridle Road Clinic (Liverpool)
Birkenhead
Soho Road Health Centre
Birmingham
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Pyramax, Placebo
- Keywords
- Pyramax, Pyronaridine, Artesunate, COVID-19, Corona virus
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyramaxDrug
Pyronaridine-Artesunate(180/60mg) tablet for 3days.
PlaceboDrug
Placebo tablet for 3days.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Pyramax tablet Receives: Drug: Pyramax |
| Control | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
Measured: follow up to Day29
Secondary outcomes (8)
Time to sustained recovery (discharge) in hospitalized subjects (days)
Measured: follow up to Day29
29-day mortality after the first dose of the investigational product
Measured: 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
Measured: Day3, Day7, Day14, Day21, Day29
NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline
Measured: 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
Measured: 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
Measured: follow up to Day29
Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14
Measured: 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
Measured: follow up to Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start18 Oct 2021
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084911
- Sponsor's protocol ID
- SP-PA-COV-301
- Status last verified
- Jun 2023
- First submitted
- 19 Oct 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05084911
- Acronym / sponsor ID
- SP-PA-COV-301
- Conditions
- COVID-19
- Keywords
- Pyramax, Pyronaridine, Artesunate, COVID-19, Corona virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,807 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: PyramaxPyramax tablet |
| Control | Placebo comparator | Drug: PlaceboPlacebo tablet |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult males and females aged 19 years or older (or minimum age for adulthood or for informed consent below 19 years for each country)
- Patients with body weight ≥45 kg at screening
- Patients with COVID-19 confirmed by RT-PCR before randomization
- 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
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyramaxPyronaridine-Artesunate(180/60mg) tablet for 3days. | Drug | Test |
| PlaceboPlacebo tablet for 3days. | Drug | Control |
Primary outcome
Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
Time frame: follow up to Day29
8 secondary outcomes
Time to sustained recovery (discharge) in hospitalized subjects (days)
Time frame: follow up to Day29
29-day mortality after the first dose of the investigational product
Time frame: 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
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
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
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
Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
66 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pyramax in people with COVID-19, run by Shin Poong Pharmaceutical Co. Ltd. at 66 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in South Korea, Colombia, Poland, Argentina, Chile and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29. (time frame: follow up to Day29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.