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

NCT05352347 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1134

Last updated 2023-03-21

No results posted yet for this study

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

Interventions

DRUG

NuSepin® 0.2 mg/kg

NuSepin® 0.2 mg/kg in 100mL NS bid

DRUG

NuSepin® 0.4 mg/kg

NuSepin® 0.4 mg/kg in 100mL NS bid

DRUG

Placebo

Normal saline (NS) 100mL bid

Sponsors & Collaborators

  • Shaperon

    lead INDUSTRY

Principal Investigators

  • Seung-Yong Seong, Dr. · Shaperon Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352347 on ClinicalTrials.gov