Clincosm LogoSign in Get a demo

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

Sponsor
Shaperon (Industry)
Overall Status
Completed
CT.gov ID
NCT04565379
Collaborator
(none)
64
Enrollment
5
Locations
3
Arms
6.6
Actual Duration (Months)
12.8
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: NuSepin® 0.1 mg
  • Drug: NuSepin® 0.2 mg
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
64 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 :
Sep 24, 2020
Actual Primary Completion Date :
Apr 13, 2021
Actual Study Completion Date :
Apr 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline [Day 15 and Day 29]

  2. Clinical Status assessed by the six-category ordinal scale at fixed time points [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 [Up to Day 29]

  4. All-cause mortality [Up to Day 29]

  5. Duration (days) of mechanical ventilation [Up to Day 29]

  6. Duration (days) of extracorporeal membrane oxygenation [Up to Day 29]

  7. Duration (days) of supplemental oxygenation [Up to Day 29]

  8. Length of hospital stay (days) [Up to Day 29]

  9. Length of ICU stay (days) [Up to Day 29]

  10. Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups [Day 15 and Day 29]

Other Outcome Measures

  1. Serum level of TNF-α in pg/ml [Day 0, 4, 9, 15 and 29]

  2. Serum level of IL-1β in pg/ml [Day 0, 4, 9, 15 and 29]

  3. Serum level of IL-6 in pg/ml [Day 0, 4, 9, 15 and 29]

  4. Serum level of IL-8 in pg/ml [Day 0, 4, 9, 15 and 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
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

  1. Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109
  • L

  1. Patients with SpO2 ≤ 94% on room air or Pa02/FI02 ratio < 300mgHg at screening

  2. Patients capable to give consent and who have signed the informed consent form before any trial related assessment.

  3. 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.

  4. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 "Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic Cluj-Napoca Romania
2 Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults Craiova Romania
3 "Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department Iaşi Romania
4 Ramnicu Sarat Clinical Hospital Ramnicu Sarat Romania 125300
5 "Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department Suceava Romania

Sponsors and Collaborators

  • Shaperon

Investigators

  • Study Chair: Seung-Yong Seong, Dr., Shaperon Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shaperon
ClinicalTrials.gov Identifier:
NCT04565379
Other Study ID Numbers:
  • Shaperon001
  • 2020-003107-34
First Posted:
Sep 25, 2020
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Pneumonia

Study Results

No Results Posted as of Jan 28, 2022