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

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ClinicalTrials.gov Identifier: NCT04565379
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
COVID19 Pneumonia Drug: NuSepin® 0.1 mg Drug: NuSepin® 0.2 mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




Primary Outcome Measures :
  1. Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days) [ Time Frame: Day 29 ]

Secondary Outcome Measures :
  1. Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline [ Time Frame: Day 15 and Day 29 ]
  2. Clinical Status assessed by the six-category ordinal scale at fixed time points [ Time Frame: Day 1, 4, 9, 15 and 29 ]
    Minimum value being 1, Maximum value being 6. Smaller the number, better the clinical status & outcome

  3. Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours [ Time Frame: Up to Day 29 ]
  4. All-cause mortality [ Time Frame: Up to Day 29 ]
  5. Duration (days) of mechanical ventilation [ Time Frame: Up to Day 29 ]
  6. Duration (days) of extracorporeal membrane oxygenation [ Time Frame: Up to Day 29 ]
  7. Duration (days) of supplemental oxygenation [ Time Frame: Up to Day 29 ]
  8. Length of hospital stay (days) [ Time Frame: Up to Day 29 ]
  9. Length of ICU stay (days) [ Time Frame: Up to Day 29 ]
  10. Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups [ Time Frame: Day 15 and Day 29 ]

Other Outcome Measures:
  1. Serum level of TNF-α in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]
  2. Serum level of IL-1β in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]
  3. Serum level of IL-6 in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]
  4. Serum level of IL-8 in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565379


Contacts
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Contact: David Song +82-2-6083-8318 shsong@shaperon.com

Locations
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Romania
"Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic Recruiting
Cluj-Napoca, Romania
Contact: Cosmina Magdau, Dr.       cmagdau@yahoo.com   
Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults Recruiting
Craiova, Romania
Contact: Iulian Diaconescu, Dr.       diaconescu_ig@yahoo.com   
"Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department Recruiting
Iaşi, Romania
Contact: Catalina Luca, Dr./Prof.       catalina_luca2006@yahoo.com   
Ramnicu Sarat Clinical Hospital Recruiting
Ramnicu Sarat, Romania, 125300
Contact: Andrei Cemurtan, Dr.    0040755459704    acemurtan@gmail.com   
"Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department Recruiting
Suceava, Romania
Contact: Olga Caliman-Sturdza, Dr.       sturdza_olga@yahoo.com   
Sponsors and Collaborators
Shaperon
Investigators
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Study Chair: Seung-Yong Seong, Dr. Shaperon Inc.
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Responsible Party: Shaperon
ClinicalTrials.gov Identifier: NCT04565379    
Other Study ID Numbers: Shaperon001
2020-003107-34 ( EudraCT Number )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases