Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients
Primary Purpose
COVID19 Pneumonia
Status
Completed
Phase
Phase 2
Locations
Romania
Study Type
Interventional
Intervention
NuSepin® 0.1 mg
NuSepin® 0.2 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID19 Pneumonia
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109
- L
- 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
Exclusion Criteria
- 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.
Sites / Locations
- "Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic
- Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults
- "Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department
- Ramnicu Sarat Clinical Hospital
- "Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
NuSepin® 0.1 mg
NuSepin® 0.2 mg
Placebo
Arm Description
NuSepin® 0.1 mg/kg in 100 ml normal saline infusion
NuSepin® 0.2 mg/kg in 100 ml normal saline infusion
100 ml normal saline infusion
Outcomes
Primary Outcome Measures
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
Secondary Outcome Measures
Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline
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
Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours
All-cause mortality
Duration (days) of mechanical ventilation
Duration (days) of extracorporeal membrane oxygenation
Duration (days) of supplemental oxygenation
Length of hospital stay (days)
Length of ICU stay (days)
Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04565379
Brief Title
Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaperon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NuSepin® 0.1 mg
Arm Type
Active Comparator
Arm Description
NuSepin® 0.1 mg/kg in 100 ml normal saline infusion
Arm Title
NuSepin® 0.2 mg
Arm Type
Active Comparator
Arm Description
NuSepin® 0.2 mg/kg in 100 ml normal saline infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 ml normal saline infusion
Intervention Type
Drug
Intervention Name(s)
NuSepin® 0.1 mg
Intervention Description
NuSepin® 0.1 mg
Intervention Type
Drug
Intervention Name(s)
NuSepin® 0.2 mg
Intervention Description
NuSepin® 0.2 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline
Primary Outcome Measure Information:
Title
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline
Time Frame
Day 15 and Day 29
Title
Clinical Status assessed by the six-category ordinal scale at fixed time points
Description
Minimum value being 1, Maximum value being 6. Smaller the number, better the clinical status & outcome
Time Frame
Day 1, 4, 9, 15 and 29
Title
Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours
Time Frame
Up to Day 29
Title
All-cause mortality
Time Frame
Up to Day 29
Title
Duration (days) of mechanical ventilation
Time Frame
Up to Day 29
Title
Duration (days) of extracorporeal membrane oxygenation
Time Frame
Up to Day 29
Title
Duration (days) of supplemental oxygenation
Time Frame
Up to Day 29
Title
Length of hospital stay (days)
Time Frame
Up to Day 29
Title
Length of ICU stay (days)
Time Frame
Up to Day 29
Title
Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups
Time Frame
Day 15 and Day 29
Other Pre-specified Outcome Measures:
Title
Serum level of TNF-α in pg/ml
Time Frame
Day 0, 4, 9, 15 and 29
Title
Serum level of IL-1β in pg/ml
Time Frame
Day 0, 4, 9, 15 and 29
Title
Serum level of IL-6 in pg/ml
Time Frame
Day 0, 4, 9, 15 and 29
Title
Serum level of IL-8 in pg/ml
Time Frame
Day 0, 4, 9, 15 and 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
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
Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109
L
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
Exclusion Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Yong Seong, Dr.
Organizational Affiliation
Shaperon Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
"Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic
City
Cluj-Napoca
Country
Romania
Facility Name
Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults
City
Craiova
Country
Romania
Facility Name
"Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department
City
Iaşi
Country
Romania
Facility Name
Ramnicu Sarat Clinical Hospital
City
Ramnicu Sarat
ZIP/Postal Code
125300
Country
Romania
Facility Name
"Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department
City
Suceava
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients
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