Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients

Phase 2

Completed

• Conditions: COVID19 Pneumonia
• Interventions: Drug: Placebo; Drug: NuSepin® 0.1 mg; Drug: NuSepin® 0.2 mg

• Registration Number: NCT04565379
• Lead Sponsor: Shaperon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study Start: 2020-09-24
• Study First Posted: 2020-09-25
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	100 ml normal saline infusion
NuSepin® 0.1 mg	NuSepin® 0.1 mg	NuSepin® 0.1 mg/kg in 100 ml normal saline infusion
NuSepin® 0.2 mg	NuSepin® 0.2 mg	NuSepin® 0.2 mg/kg in 100 ml normal saline infusion

Primary Outcome Measures

Name	Time	Method
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)	Day 29

Secondary Outcome Measures

Name	Time	Method
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	Minimum value being 1, Maximum value being 6. Smaller the number, better the clinical status \& outcome
All-cause mortality	Up to Day 29
Length of hospital stay (days)	Up to Day 29

Trial Locations

Locations (5)

"Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic; 🇷🇴 Cluj-Napoca, Romania

Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults; 🇷🇴 Craiova, Romania

"Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department; 🇷🇴 Iaşi, Romania

Ramnicu Sarat Clinical Hospital; 🇷🇴 Ramnicu Sarat, Romania

"Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department; 🇷🇴 Suceava, Romania