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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

About this trial

This is an interventional treatment trial for COVID19 Pneumonia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT04565379

First Posted

September 23, 2020

Last Updated

January 27, 2022

Sponsor

Shaperon

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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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