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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    1134
  • sponsor
    Shaperon
Updated on 15 May 2022

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

Details
Condition COVID-19 Pneumonia
Treatment Placebo, NuSepin® 0.2 mg/kg, NuSepin® 0.4 mg/kg
Clinical Study IdentifierNCT05352347
SponsorShaperon
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
An individual with an oxygen saturation of 94% or less in room air condition at the time of randomization; and 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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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