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COVID-19Phase 2NCT04475107

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

A Phase 2 study testing Pyronaridine-Artesunate in people with COVID-19, run by Shin Poong Pharmaceutical Co. Ltd. at 13 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
Pyronaridine-Artesunate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
13 sitesSouth Korea
Study dates
9 Jul 2020to 15 Apr 2021
Phase
Phase 2
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

  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

South Korea13 sites

  • Korea University Ansan Hospital

    Ansan

  • Chungnam national University Hospital

    Daejeon

  • Inha University Hospital

    Incheon

  • Gangnam Severance Hospital

    Seoul

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyungpook National University Hospital

    Seoul

  • National Medical Center

    Seoul

  • Sahmyook Medical Center

    Seoul

  • Seoul Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • The Catholic University of Korea, Eunpyeong St. Marys' Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

About this study

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

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.

Conditions
COVID-19
Being tested
Pyronaridine-Artesunate, 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.

  • Pyronaridine-ArtesunateDrug

    Pyramax

  • PlaceboDrug

    Placebo

Study groups in NCT04475107
Study groupRoleWhat they receive
Arm AExperimentalPyramax (Pyronaridine 180mg/ Artesunate 60mg)
Receives: Drug: Pyronaridine-Artesunate
Arm BPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*

    • Patients who are rRT-PCR negative for COVID-19

    Measured: Day 7

Secondary outcomes (7)

  1. Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline

    Measured: Day 3, 7, 10, 14

  2. Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*

    • Patients who are rRT-PCR negative for COVID-19

    Measured: Day 3, 10, 14

  3. Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline

    Measured: Day 3, 7, 10, 14, 28

  4. Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline

    Measured: Day 3, 7, 10, 14, 28

  5. Time to achieve normalization of body temperature, post-dose

    Measured: Day 3, 7, 10, 14, 28

  6. Time to achieve normalization of respiratory rate, post-dose

    Measured: Day 3, 7, 10, 14, 28

  7. Time to achieve normalization of oxygen saturation, post-dose

    Measured: Day 3, 7, 10, 14, 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2020
  2. Study start9 Jul 2020
  3. Primary completion25 Mar 2021
  4. Study completion15 Apr 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04475107
Sponsor's protocol ID
SP-PA-COV-201
Status last verified
Apr 2021
First submitted
14 Jul 2020
Last updated
1 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyronaridine-Artesunate in people with COVID-19, run by Shin Poong Pharmaceutical Co. Ltd. at 13 sites in South Korea.

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 17 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 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose* (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04475107.

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 1 Jun 2021.

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