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COVID-19 PneumoniaPhase 2/3NCT05352347

Phase 2b/3 Trial of NuSepin® in COVID-19 Pneumonia Patients

A Phase 2/3 study testing NuSepin® 0.2 mg/kg and NuSepin® 0.4 mg/kg in people with COVID-19 Pneumonia, run by Shaperon at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
NuSepin® 0.2 mg/kg and NuSepin® 0.4 mg/kg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,134 participants
Where
1 siteSouth Korea
Study dates
12 Apr 2022to 31 Dec 2024
Phase
Phase 2/3
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

  • An individual who or whose legally authorized representative has fully informed of all pertinent aspect of the trial and IMP, voluntarily decided to participate in the trial and adherence to the trial-related requirements, and provided a written informed consent
  • An adult man or woman aged between 19 years (or age of majority in his/her country) and 80 years.
  • A hospitalized patient with laboratory-confirmed SARS-CoV-2 infection by PCR test within 10 days (240 hours) prior to randomization.
  • At the time of randomization; whose clinical status is stage 4 (oxygenation by facial mask or nasal cannula) or 5 (non-invasive ventilation or high flow oxygen) on WHO 8-point ordinal scale
  • Pneumonia that satisfies all the following criteria at the time of randomization
  • Planned first dosing of the IMP not later than 2 days after the initiation of standard of care (SOC), when given in combination with SOC for severe Illness (according to NIH Clinical Spectrum of SARS-CoV-2 Infection)
  • A score of 5 points or more ("think sepsis") on the NEWS 2 scale at the time of randomization

Who cannot join

  • A patient whose clinical status is stage 3 or lower on the WHO 8-point ordinal scale (WHO 8-OS) at the time of randomization
  • An individual who requires endotracheal intubation, mechanical ventilation (WHO 8-OS stage 6), or extracorporeal membrane oxygen therapy (stage 7) at the time of randomization
  • A patient with multiorgan failure, shock, acute respiratory syndrome (ARDS)
  • A patient with renal dysfunction defined by eGFR less than 30mL/min/1.73m², or the use of hemodialysis or hemofiltration
  • Cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction
  • Any of the following laboratory test results at the time of screening:
  • An individual with HIV-positive results or who requires antiviral treatments against active hepatitis (HBV, HCV) and etc.

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565

    Joong-Sik Eom, 386js@naver.com

    Recruiting

Other trials in South Korea

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients

A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients

Being tested
NuSepin® 0.2 mg/kg, NuSepin® 0.4 mg/kg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NuSepin® 0.2 mg/kgDrug

    NuSepin® 0.2 mg/kg in 100mL NS bid

  • NuSepin® 0.4 mg/kgDrug

    NuSepin® 0.4 mg/kg in 100mL NS bid

  • PlaceboDrug

    Normal saline (NS) 100mL bid

Study groups in NCT05352347
Study groupRoleWhat they receive
NuSepin® 0.2 mg/kgActive comparatorNuSepin® 0.2 mg/kg in 100mL NS bid
Receives: Drug: NuSepin® 0.2 mg/kg
NuSepin® 0.4 mg/kgActive comparatorNuSepin® 0.4 mg/kg in 100mL NS bid
Receives: Drug: NuSepin® 0.4 mg/kg
PlaceboPlacebo comparatorNormal saline (NS) 100mL bid
Receives: Drug: Placebo

What is being measured

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

  1. Time to improvement of at least 2 categories relative to the first dosing date of the Investigational Medicinal Product (randomization date) on an 8-point ordinal scale (WHO 8-point ordinal scale) of clinical status up to day 29 [Phase 2b]

    Measured: Day 29

  2. Time to discharge relative to the first dosing date of the IMP (randomization date) [Phase 3]

    Measured: Day 29

Secondary outcomes (10)

  1. WHO 8-point ordinal scale

    The proportion of subjects with categories of 2 or less (outpatient condition); and 3 or less (hospitalized, no oxygen treatment) at day 8, 15 and 29 and etc.

    Measured: Day 29

  2. NEWS 2

    Time to normalization of vital signs that lasts 24 hours or more (score 0 on NEWS2 that lasts 24 hours or more) and etc.

    Measured: Day 29

  3. the use of ventilatory assistance

    The proportion of subjects undergoing a ventilatory assistance (facial mask, low-flow oxygen cannula, high-flow oxygen cannula, Non-invasive ventilation, Invasive Mechanical Ventilation/ECMO) at day 8, day 15, and day 29; and the days of each ventilatory assistance since the first dosing date of IMP (randomization date) up to day 29

    Measured: Day 29

  4. Hospitalization and ICU Admission

    Proportion of subjects transferred to ICU and the duration of ICU admission (date of admission to ICU ~ discharge date) since the first dosing date of IMP (randomization date) up to day 29 and etc.

    Measured: Day 29

  5. Survival

    All-cause mortality; follow-up until discharge, or up to 60 days for patients who are still hospitalized at day 29 of the first IMP dosing (randomization date)

    Measured: Day 29

  6. biomarkers

    Proportions of subjects whose inflammatory-related biomarkers at baseline, day 4, day 8, day 15, day 29 are within the normal range (① TNF-α, ② IL-1β, ③ IL-6, ④ IL-8 ⑤ IL-18 ⑥ CRP) and etc.

    Measured: Day 29

  7. Cytokine release syndrome

    The proportion of subjects with a decrease of at least 1 category according to an ASTCT Consensus Grading step for Cytokine Release Syndrome

    Measured: Day 29

  8. Viral burden

    Proportion of patients who become negative for viral titer at each assessment time point since the first dosing date of IMP and etc.

    Measured: Day 29

  9. Compliance

    Compliance of the study drugs (days of dosing with the study drugs and total dose administered)

    Measured: Day 29

  10. Safety Endpoints

    The incidence and characteristics of adverse events after administration of IMP and etc.

    Measured: Day 29

Timeline

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

  1. First posted28 Apr 2022
  2. Study start12 Apr 2022
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352347
Sponsor's protocol ID
ShaperonC002
Status last verified
Apr 2022
First submitted
22 Apr 2022
Last updated
21 Mar 2023
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 2/3 study testing NuSepin® 0.2 mg/kg and NuSepin® 0.4 mg/kg in people with COVID-19 Pneumonia, run by Shaperon at 1 site 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to improvement of at least 2 categories relative to the first dosing date of the Investigational Medicinal Product (randomization date) on an 8-point ordinal scale (WHO 8-point ordinal scale) of clinical status up to day 29 [Phase 2b] (time frame: Day 29). The study lists 2 primary outcomes in all. 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 NCT05352347.

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 21 Mar 2023.

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