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CompletedNCT04565379Updated Jan 28, 2022

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

A Phase 2 interventional study of NuSepin® 0.1 mg and NuSepin® 0.2 mg in COVID19 Pneumonia, sponsored by Shaperon. Completed at 5 sites in Romania. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Shaperon · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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

02

Conditions studied

  • COVID19 Pneumonia
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 64 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Shaperon is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    NuSepin® 0.1 mg

    NuSepin® 0.1 mg/kg in 100 ml normal saline infusion

    Drug: 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

  • Placebo comparator
    Placebo

    100 ml normal saline infusion

    Drug: Placebo

Interventions

  • DrugNuSepin® 0.1 mg

    NuSepin® 0.1 mg

  • DrugNuSepin® 0.2 mg

    NuSepin® 0.2 mg

  • DrugPlacebo

    Normal Saline

06

What researchers measure

Primary outcomes

  1. Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)

    Time frame: Day 29

Secondary outcomes

  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

    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

  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 outcomes

  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

07

Study locations

5 sites
  • "Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic
    Cluj-Napoca, Romania
  • Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults
    Craiova, Romania
  • "Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department
    Iaşi, Romania
  • Ramnicu Sarat Clinical Hospital
    Ramnicu Sarat, 125300, Romania
  • "Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department
    Suceava, Romania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04565379
Lead sponsor
Shaperon
Responsible party
Sponsor
First posted
Sep 25, 2020
Start date
Sep 24, 2020
Primary completion
Apr 13, 2021
Completion
Apr 13, 2021
Last update
Jan 28, 2022

Study contacts

Seung-Yong Seong, Dr.
study chair · Shaperon Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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