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

Primary Purpose

COVID-19 Pneumonia

Status

Recruiting

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

NuSepin® 0.2 mg/kg

NuSepin® 0.4 mg/kg

Placebo

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gachon University Gil Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NuSepin® 0.2 mg/kg

NuSepin® 0.4 mg/kg

Placebo

Arm Description

NuSepin® 0.2 mg/kg in 100mL NS bid

NuSepin® 0.4 mg/kg in 100mL NS bid

Normal saline (NS) 100mL bid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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

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.

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)

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.

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

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.

Compliance

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

Safety Endpoints

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

Full Information

NCT ID

NCT05352347

First Posted

April 22, 2022

Last Updated

March 20, 2023

Sponsor

Shaperon

1. Study Identification

Unique Protocol Identification Number

NCT05352347

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 12, 2022 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shaperon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NuSepin® 0.2 mg/kg

Arm Type

Active Comparator

Arm Description

NuSepin® 0.2 mg/kg in 100mL NS bid

Arm Title

NuSepin® 0.4 mg/kg

Arm Type

Active Comparator

Arm Description

NuSepin® 0.4 mg/kg in 100mL NS bid

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline (NS) 100mL bid

Intervention Type

Drug

Intervention Name(s)

NuSepin® 0.2 mg/kg

Intervention Description

NuSepin® 0.2 mg/kg in 100mL NS bid

Intervention Type

Drug

Intervention Name(s)

NuSepin® 0.4 mg/kg

Intervention Description

NuSepin® 0.4 mg/kg in 100mL NS bid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline (NS) 100mL bid

Primary Outcome Measure Information:

Title

Time Frame

Day 29

Title

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

Time Frame

Day 29

Secondary Outcome Measure Information:

Title

WHO 8-point ordinal scale

Description

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.

Time Frame

Day 29

Title

NEWS 2

Description

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

Time Frame

Day 29

Title

the use of ventilatory assistance

Description

Time Frame

Day 29

Title

Hospitalization and ICU Admission

Description

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.

Time Frame

Day 29

Title

Survival

Description

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)

Time Frame

Day 29

Title

biomarkers

Description

Time Frame

Day 29

Title

Cytokine release syndrome

Description

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

Time Frame

Day 29

Title

Viral burden

Description

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

Time Frame

Day 29

Title

Compliance

Description

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

Time Frame

Day 29

Title

Safety Endpoints

Description

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

Time Frame

Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung-Yong Seong, Dr.

Organizational Affiliation

Shaperon Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Gachon University Gil Medical Center

City

Incheon

State/Province

Namdong-gu

ZIP/Postal Code

21565

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joong-Sik Eom

386js@naver.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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