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

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

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

Study Overview

• Status: Completed
• Conditions: COVID19 Pneumonia
• Intervention / Treatment: Drug: Placebo; Drug: NuSepin® 0.1 mg; Drug: NuSepin® 0.2 mg

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania
    • "Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic
  • Craiova, Romania
    • Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults
  • Iaşi, Romania
    • "Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department
  • Ramnicu Sarat, Romania, 125300
    • Ramnicu Sarat Clinical Hospital
  • Suceava, Romania
    • "Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Male or female subjects aged between 18≤ and <80 years old
2. Laboratory-confirmed SARS-CoV-2 infection by PCR test for the first time within 144 hours prior to randomization

3. Diagnosis of pneumonia based on:

   • Radiographic infiltrates by imaging (chest x-ray, CT scan) AND
   • 3 of the following clinical symptoms: new onset cough, fever, fatigue, sputum (all day), tachypnea, dyspnea, pleuritic chest pain AND
   • CRP value > 10 mg/L

4. Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109

   • L
5. Patients with SpO2 ≤ 94% on room air or Pa02/FI02 ratio < 300mgHg at screening
6. Patients capable to give consent and who have signed the informed consent form before any trial related assessment.
7. 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.
8. Patients with NEWS2 score > 7

Exclusion Criteria

1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
2. Reduced renal function with estimated glomerular filtration rate (eGFR) < 30 ml/min or hemodialysis or hemofiltration.
3. Pregnancy or breast feeding.
4. Evidence of multiorgan failure
5. Steroid treatment by any reason within 72 hours prior to enrolment
6. Participation in any other clinical trial of an experimental agent treatment for COVID-19
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NuSepin® 0.1 mg; NuSepin® 0.1 mg/kg in 100 ml normal saline infusion	Drug: NuSepin® 0.1 mg; NuSepin® 0.1 mg
Active Comparator: NuSepin® 0.2 mg; NuSepin® 0.2 mg/kg in 100 ml normal saline infusion	Drug: NuSepin® 0.2 mg; NuSepin® 0.2 mg
Placebo Comparator: Placebo; 100 ml normal saline infusion	Drug: Placebo; Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Minimum value being 1, Maximum value being 6. Smaller the number, better the clinical status & outcome	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
Duration (days) of extracorporeal membrane oxygenation		Up to Day 29
Duration (days) of supplemental oxygenation		Up to Day 29
Length of hospital stay (days)		Up to Day 29
Length of ICU stay (days)		Up to Day 29
Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups		Day 15 and Day 29

Other Outcome Measures

Outcome Measure	Time Frame
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
Serum level of IL-8 in pg/ml	Day 0, 4, 9, 15 and 29

Collaborators and Investigators

• Sponsor: Shaperon
• Investigators: Study Chair: Seung-Yong Seong, Dr., Shaperon Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): April 13, 2021
• Study Completion (Actual): April 13, 2021

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: Shaperon001; 2020-003107-34 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No