Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 23, 2020
First Posted Date  ICMJE September 25, 2020
Last Update Posted Date March 17, 2021
Actual Study Start Date  ICMJE September 25, 2020
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days) [ Time Frame: Day 29 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline [ Time Frame: Day 15 and Day 29 ]
  • 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
  • Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours [ Time Frame: Up to Day 29 ]
  • All-cause mortality [ Time Frame: Up to Day 29 ]
  • Duration (days) of mechanical ventilation [ Time Frame: Up to Day 29 ]
  • Duration (days) of extracorporeal membrane oxygenation [ Time Frame: Up to Day 29 ]
  • Duration (days) of supplemental oxygenation [ Time Frame: Up to Day 29 ]
  • Length of hospital stay (days) [ Time Frame: Up to Day 29 ]
  • Length of ICU stay (days) [ Time Frame: Up to Day 29 ]
  • Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups [ Time Frame: Day 15 and Day 29 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline [ Time Frame: Day 15 and Day 29 ]
  • Clinical Status assessed by the six-category ordinal scale at fixed time points [ Time Frame: 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 [ Time Frame: Up to Day 29 ]
  • All-cause mortality [ Time Frame: Up to Day 29 ]
  • Duration (days) of mechanical ventilation [ Time Frame: Up to Day 29 ]
  • Duration (days) of extracorporeal membrane oxygenation [ Time Frame: Up to Day 29 ]
  • Duration (days) of supplemental oxygenation [ Time Frame: Up to Day 29 ]
  • Length of hospital stay (days) [ Time Frame: Up to Day 29 ]
  • Length of ICU stay (days) [ Time Frame: Up to Day 29 ]
  • Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups [ Time Frame: Day 15 and Day 29 ]
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2020)
  • Serum level of TNF-α in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]
  • Serum level of IL-1β in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]
  • Serum level of IL-6 in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]
  • Serum level of IL-8 in pg/ml [ Time Frame: Day 0, 4, 9, 15 and 29 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID19 Pneumonia
Intervention  ICMJE
  • Drug: NuSepin® 0.1 mg
    NuSepin® 0.1 mg
  • Drug: NuSepin® 0.2 mg
    NuSepin® 0.2 mg
  • Drug: Placebo
    Normal Saline
Study Arms  ICMJE
  • Active Comparator: NuSepin® 0.1 mg
    NuSepin® 0.1 mg/kg in 100 ml normal saline infusion
    Intervention: Drug: NuSepin® 0.1 mg
  • Active Comparator: NuSepin® 0.2 mg
    NuSepin® 0.2 mg/kg in 100 ml normal saline infusion
    Intervention: Drug: NuSepin® 0.2 mg
  • Placebo Comparator: Placebo
    100 ml normal saline infusion
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Song +82-2-6083-8318 shsong@shaperon.com
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04565379
Other Study ID Numbers  ICMJE Shaperon001
2020-003107-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaperon
Study Sponsor  ICMJE Shaperon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Seung-Yong Seong, Dr. Shaperon Inc.
PRS Account Shaperon
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP