Phase 2b/3 Trial of NuSepin® 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

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 Overview

• Status: Recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Drug: NuSepin® 0.2 mg/kg; Drug: NuSepin® 0.4 mg/kg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 1134
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: JS Lee; Phone Number: +82-2-6083-8318; Email: jslee@shaperon.com

Study Locations

• Korea, Republic of
  • Namdong-gu
    • Incheon, Namdong-gu, Korea, Republic of, 21565
      • Recruiting
      • Gachon University Gil Medical Center
      • Contact: Joong-Sik Eom; Email: 386js@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. An adult man or woman aged between 19 years (or age of majority in his/her country) and 80 years.
3. A hospitalized patient with laboratory-confirmed SARS-CoV-2 infection by PCR test within 10 days (240 hours) prior to randomization.
4. 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
5. Pneumonia that satisfies all the following criteria at the time of randomization
6. 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)
7. A score of 5 points or more ("think sepsis") on the NEWS 2 scale at the time of randomization

Exclusion Criteria:

1. 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
2. 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
3. A patient with multiorgan failure, shock, acute respiratory syndrome (ARDS)
4. A patient with renal dysfunction defined by eGFR less than 30mL/min/1.73m², or the use of hemodialysis or hemofiltration
5. Cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction
6. Any of the following laboratory test results at the time of screening:
7. An individual with HIV-positive results or who requires antiviral treatments against active hepatitis (HBV, HCV) and etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NuSepin® 0.2 mg/kg; NuSepin® 0.2 mg/kg in 100mL NS bid	Drug: NuSepin® 0.2 mg/kg; NuSepin® 0.2 mg/kg in 100mL NS bid
Active Comparator: NuSepin® 0.4 mg/kg; NuSepin® 0.4 mg/kg in 100mL NS bid	Drug: NuSepin® 0.4 mg/kg; NuSepin® 0.4 mg/kg in 100mL NS bid
Placebo Comparator: Placebo; Normal saline (NS) 100mL bid	Drug: Placebo; Normal saline (NS) 100mL bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 29
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.	Day 29
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	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.	Day 29
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)	Day 29
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.	Day 29
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	Day 29
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.	Day 29
Compliance	Compliance of the study drugs (days of dosing with the study drugs and total dose administered)	Day 29
Safety Endpoints	The incidence and characteristics of adverse events after administration of IMP and etc.	Day 29

Collaborators and Investigators

• Sponsor: Shaperon
• Investigators: Study Chair: Seung-Yong Seong, Dr., Shaperon Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: ShaperonC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No