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

NCT04565379 | Completed Phase 2

• 2 other identifiers: Shaperon0012020-003107-34
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

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

Conditions

COVID19 Pneumonia

Outcome Measures

Primary Outcomes (1)

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

  Day 29

Secondary Outcomes (10)

• Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline

  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

• Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours

  Up to Day 29

• All-cause mortality

  Up to Day 29

• Duration (days) of mechanical ventilation

  Up to Day 29

Other Outcomes (4)

• Serum level of TNF-α in pg/ml

  Day 0, 4, 9, 15 and 29

• Serum level of IL-1β in pg/ml

  Day 0, 4, 9, 15 and 29

• Serum level of IL-6 in pg/ml

  Day 0, 4, 9, 15 and 29

Study Arms (3)

NuSepin® 0.1 mg

ACTIVE COMPARATOR

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

Drug: NuSepin® 0.1 mg

NuSepin® 0.2 mg

ACTIVE COMPARATOR

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

Drug: NuSepin® 0.2 mg

Placebo

PLACEBO COMPARATOR

100 ml normal saline infusion

Drug: Placebo

Interventions

NuSepin® 0.1 mg DRUG

NuSepin® 0.1 mg

NuSepin® 0.1 mg

NuSepin® 0.2 mg DRUG

NuSepin® 0.2 mg

NuSepin® 0.2 mg

Placebo DRUG

Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged between 18≤ and \<80 years old
• Laboratory-confirmed SARS-CoV-2 infection by PCR test for the first time within 144 hours prior to randomization
• Diagnosis of pneumonia based on:
• Radiographic infiltrates by imaging (chest x-ray, CT scan) AND
• of the following clinical symptoms: new onset cough, fever, fatigue, sputum (all day), tachypnea, dyspnea, pleuritic chest pain AND
• CRP value \> 10 mg/L
• Patients with blood leukocyte count \> 4.0 x 109 /L and lymphocyte count \> 0.7 x 109
• Patients with SpO2 ≤ 94% on room air or Pa02/FI02 ratio \< 300mgHg at screening
• Patients capable to give consent and who have signed the informed consent form before any trial related assessment.
• Medically accepted effective contraception for women of childbearing potential (WOCBP) which should be continued until at least 90 days after the last dose of trial treatment.
• Patients with NEWS2 score \> 7

You may not qualify if:

• Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
• Reduced renal function with estimated glomerular filtration rate (eGFR) \< 30 ml/min or hemodialysis or hemofiltration.
• Pregnancy or breast feeding.
• Evidence of multiorgan failure
• Steroid treatment by any reason within 72 hours prior to enrolment
• Participation in any other clinical trial of an experimental agent treatment for COVID-19
• Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.

Sponsors & Collaborators

• Shaperon: lead

Study Sites (5)

"Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic

Cluj-Napoca, Romania

Location

Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults

Craiova, Romania

Location

"Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department

Iași, Romania

Location

Ramnicu Sarat Clinical Hospital

Râmnicu Sărat, 125300, Romania

Location

"Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department

Suceava, Romania

Location

Study Officials

• Seung-Yong Seong, Dr.

  Shaperon Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 25, 2020
• Study Start: September 24, 2020
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

RO (5)