A Randomized, Double Blind, Placebo-controlled, Phase 2 Clinical Trial to Investigate the Efficacy and Safety of 2 Doses of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients

Shaperon5 sites in 1 country64 target enrollmentSeptember 24, 2020

ConditionsCOVID19 Pneumonia

InterventionsNuSepin® 0.1 mg NuSepin® 0.2 mg Placebo

DrugsNuSepin® 0.1 mg NuSepin® 0.2 mg Placebo

Overview

Phase: Phase 2
Intervention: NuSepin® 0.1 mg
Conditions: COVID19 Pneumonia
Sponsor: Shaperon
Enrollment: 64
Locations: 5
Primary Endpoint: Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients

Registry

clinicaltrials.gov

Start Date

September 24, 2020

End Date

April 13, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shaperon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

NuSepin® 0.1 mg

NuSepin® 0.1 mg/kg in 100 ml normal saline infusion

Intervention: NuSepin® 0.1 mg

NuSepin® 0.2 mg

NuSepin® 0.2 mg/kg in 100 ml normal saline infusion

Intervention: NuSepin® 0.2 mg

Placebo

100 ml normal saline infusion

Intervention: Placebo

Outcomes

Primary Outcomes

Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)

Time Frame: Day 29

Secondary Outcomes

Duration (days) of supplemental oxygenation(Up to Day 29)
Length of ICU stay (days)(Up to Day 29)
Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours(Up to Day 29)
Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline(Day 15 and Day 29)
Duration (days) of mechanical ventilation(Up to Day 29)
Duration (days) of extracorporeal membrane oxygenation(Up to Day 29)
Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups(Day 15 and Day 29)
Clinical Status assessed by the six-category ordinal scale at fixed time points(Day 1, 4, 9, 15 and 29)
All-cause mortality(Up to Day 29)
Length of hospital stay (days)(Up to Day 29)