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

Phase 2

Recruiting

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: NuSepin® 0.4 mg/kg; Drug: Placebo; Drug: NuSepin® 0.2 mg/kg

• Registration Number: NCT05352347
• Lead Sponsor: Shaperon

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-12
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-28
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NuSepin® 0.4 mg/kg	NuSepin® 0.4 mg/kg	NuSepin® 0.4 mg/kg in 100mL NS bid
Placebo	Placebo	Normal saline (NS) 100mL bid
NuSepin® 0.2 mg/kg	NuSepin® 0.2 mg/kg	NuSepin® 0.2 mg/kg in 100mL NS bid

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
biomarkers	Day 29	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.
WHO 8-point ordinal scale	Day 29	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.
Compliance	Day 29	Compliance of the study drugs (days of dosing with the study drugs and total dose administered)
Cytokine release syndrome	Day 29	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	Day 29	Proportion of patients who become negative for viral titer at each assessment time point since the first dosing date of IMP and etc.
Safety Endpoints	Day 29	The incidence and characteristics of adverse events after administration of IMP and etc.
the use of ventilatory assistance	Day 29	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
NEWS 2	Day 29	Time to normalization of vital signs that lasts 24 hours or more (score 0 on NEWS2 that lasts 24 hours or more) and etc.
Hospitalization and ICU Admission	Day 29	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	Day 29	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)

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Namdong-gu, Korea, Republic of