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

NCT05352347 | Unknown Phase 2

• 1 other identifier: ShaperonC002
• Study Type: interventional
• Target: 1,134
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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]

  Day 29

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

  Day 29

Secondary Outcomes (10)

• WHO 8-point ordinal scale

  Day 29

• NEWS 2

  Day 29

• the use of ventilatory assistance

  Day 29

• Hospitalization and ICU Admission

  Day 29

• Survival

  Day 29

Study Arms (3)

NuSepin® 0.2 mg/kg

ACTIVE COMPARATOR

NuSepin® 0.2 mg/kg in 100mL NS bid

Drug: NuSepin® 0.2 mg/kg

NuSepin® 0.4 mg/kg

ACTIVE COMPARATOR

NuSepin® 0.4 mg/kg in 100mL NS bid

Drug: NuSepin® 0.4 mg/kg

Placebo

PLACEBO COMPARATOR

Normal saline (NS) 100mL bid

Drug: Placebo

Interventions

NuSepin® 0.2 mg/kg DRUG

NuSepin® 0.2 mg/kg in 100mL NS bid

NuSepin® 0.2 mg/kg

NuSepin® 0.4 mg/kg DRUG

NuSepin® 0.4 mg/kg in 100mL NS bid

NuSepin® 0.4 mg/kg

Placebo DRUG

Normal saline (NS) 100mL bid

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaperon: lead

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

RECRUITING

Study Officials

• Seung-Yong Seong, Dr.

  Shaperon Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: April 12, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 21, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)