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

NCT ID: NCT05352347

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NuSepin® 0.2 mg/kg

NuSepin® 0.2 mg/kg in 100mL NS bid

Group Type: ACTIVE_COMPARATOR

NuSepin® 0.2 mg/kg

Intervention Type: DRUG

NuSepin® 0.2 mg/kg in 100mL NS bid

NuSepin® 0.4 mg/kg

NuSepin® 0.4 mg/kg in 100mL NS bid

Group Type: ACTIVE_COMPARATOR

NuSepin® 0.4 mg/kg

Intervention Type: DRUG

NuSepin® 0.4 mg/kg in 100mL NS bid

Placebo

Normal saline (NS) 100mL bid

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline (NS) 100mL bid

Interventions

NuSepin® 0.2 mg/kg

NuSepin® 0.2 mg/kg in 100mL NS bid

Intervention Type: DRUG

NuSepin® 0.4 mg/kg

NuSepin® 0.4 mg/kg in 100mL NS bid

Intervention Type: DRUG

Placebo

Normal saline (NS) 100mL bid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaperon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seung-Yong Seong, Dr.

Role: STUDY_CHAIR

Shaperon Inc.

Locations

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Joong-Sik Eom

Role: primary

386js@naver.com

Other Identifiers

ShaperonC002

Identifier Type: -

Identifier Source: org_study_id