Clinical trial NCT05352347: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID-19 Pneumonia
Lead sponsor: Shaperon
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 1134
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 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]
timeFrame: Day 29
measure: Time to discharge relative to the first dosing date of the IMP (randomization date) [Phase 3]
timeFrame: Day 29
Secondary outcomes:
measure: WHO 8-point ordinal scale
timeFrame: Day 29
measure: NEWS 2
timeFrame: Day 29
measure: the use of ventilatory assistance
timeFrame: Day 29
measure: Hospitalization and ICU Admission
timeFrame: Day 29
measure: Survival
timeFrame: Day 29
measure: biomarkers
timeFrame: Day 29
measure: Cytokine release syndrome
timeFrame: Day 29
measure: Viral burden
timeFrame: Day 29
measure: Compliance
timeFrame: Day 29
measure: Safety Endpoints
timeFrame: Day 29
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
Study officials:
affiliation: Shaperon Inc.
name: Seung-Yong Seong, Dr.
role: STUDY_CHAIR
References: