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Phase 2b/3 Trial of NuSepin® in COVID-19 Pneumonia Patients | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

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

NCT05352347•Shaperon

View on ClinicalTrials.gov

Summary

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Key Dates

Start Date

April 12, 2022

Primary Completion Date

November 30, 2024

Completion Date

December 31, 2024

Last Updated

March 21, 2023

Enrollment

1,134

ESTIMATED participants

Conditions

COVID-19 Pneumonia

Interventions

NuSepin® 0.2 mg/kg

DRUG

NuSepin® 0.4 mg/kg

DRUG

Placebo

DRUG

Corona Virus Disease 2019 Cohort Study

NCT06927622

COVID-19 PneumoniaCOVID-19 Pandemic+1 more

View study

COMPLETEDNA

HRQOL of Life After ECMO Due to COVID-19.

NCT05531032

ARDSCOVID-19 Pneumonia+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Corona Virus Disease 2019 Cohort Study

HRQOL of Life After ECMO Due to COVID-19.

Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)

Cerebral Autoregulation and COVID-19

Cromolyn Sodium for Treatment of COVID-19 Pneumonia

Tele-rehabilitation Program After Hospitalization for COVID-19