AzTrials
AzTrials

COVID-19Phase 2NCT05633420

Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

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

Completed

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

Official record
Search all trials

Trial summary

This study is a multi-center, single-arm, open-label, pilot clinical trial to explore 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?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesSouth Korea
Study dates
24 Jul 2022to 20 Nov 2022
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 or older
  • Patients with body weight ≥45 kg at screening
  • Patients who were first confirmed with COVID-19 through Real-Time Polymerase Chain Reaction (RT-PCR) or antigen test within 96 hours of baseline (those who have no history of confirmed COVID-19 within 3 months from the time of screening)
  • Patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before screening, 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 or higher level of care, or who may be potentially transferred to another hospital other than the institution within 72 hours, with decreased oxygen saturation (<94%) at screening.
  • Patients who have received or who have plans 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
  • Patients with a known allergic reaction to the active ingredients (pyronaridine tetraphosphate, artesunate) and other ingredients of 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 investigational product
Show all 9Show fewer
  • Pregnant, breast-feeding or females with positive pregnancy test at screening
  • Females and males who have a child-bearing plan or who are unwilling to commit to the use of the highly effective methods of contraception during the study period and for 3 months after the study period, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence and surgical sterilization (vasectomy, tubal ligation, etc.)
  • Patients whom the investigator considers inappropriate for the study due to chronic underlying disease or other reasons

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 10380

  • Inha University Hospital

    Incheon, 22332

Other trials in South Korea

About this study

Official title: A Multi-Center Single Arm, Open-label, Pilot Clinical Trial to Explore Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients

This study is a multi-center, single-arm, open-label, pilot clinical trial to explore efficacy and safety of Pyramax in mild to moderate COVID-19 patients

Read the detailed description

This study is a multi-center, single-arm, open-label, pilot clinical trial to explore the efficacy and safety of Pyramax Tab. in patients diagnosed with mild to moderate Coronavirus Disease-19 (COVID-19).

Major inclusion criteria are eligible patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before the screening, who do not need adjunctive oxygen therapy.

Subjects eligible to participate in this study will be enrolled and will take Investigational Product once a day for 3 days.

Subjects will participate in this study for 29 days in total, and subjects will follow the procedure in accordance with the Schedule of Clinical Trial Events to evaluate efficacy and safety after administration of Investigational Product.

Even though subjects are released from quarantine or discharged after showing clinical improvements, subjects should continue to visit hospitals for follow-up until 29 days in accordance with scheduled visit. The criteria of specific discharge (release from quarantine) for confirmed COVID-19 patients with symptoms should follow the latest version of the infectious disease prevention and control guideline.

Conditions
COVID-19
Being tested
Pyramax
Keywords
Pyramax, pyronaridine-artesunate, COVID-19, SARS-CoV-2
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

    Also called pyronaridine-artesunate

    Participant body weight

    • ≥65 kg (Pyramax 4 tablets)
    • ≥45 kg and <65 kg (Pyramax 3 tablets)
Study groups in NCT05633420
Study groupRoleWhat they receive
PyramaxExperimentalpyronaridine-artesunate (180/160 mg)
Receives: Drug: Pyramax

What is being measured

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

  1. Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product

    Time took for subjects with positive infectious viable virus from virus culture at the baseline to get first negative infectious virus test result

    Measured: follow up to Day29

Secondary outcomes (4)

  1. Change from baseline in SARS-CoV-2 infectious virus titer by viral culture

    Changes in COVID-19 infectious viral titer compared to the baseline

    Measured: follow up to Day14

  2. Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR

    Changes in COVID-19 viral RNA load compared to the baseline

    Measured: follow up to Day14

  3. Percentage of subjects requiring acute treatment for more than 24 hours in a hospital or acute treatment facility due to COVID-19 or who have died until 29 days after administration

    Proportion of participants with progression to severe COVID-19 through Day 29 assessed by the composite outcome of COVID-19-related adjudicated hospitalization or oxygen therapy or more extensive care or death from any cause

    Measured: follow up to Day29

  4. Percentage of patients with new and aggravated pneumonia until 29 days after administration of the investigational product

    Defined as new occurrence or aggravation of existing pneumonia

    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.

  1. First posted1 Dec 2022
  2. Study start24 Jul 2022
  3. Primary completion6 Sep 2022
  4. Study completion20 Nov 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05633420
Sponsor's protocol ID
SP-PA-COV-204
Status last verified
Nov 2022
First submitted
30 Nov 2022
Last updated
2 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyramax in people with COVID-19, run by Shin Poong Pharmaceutical Co. Ltd. at 2 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 9 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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?

Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product (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?

On the ClinicalTrials.gov record for NCT05633420.

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 2 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in