Clinical trial NCT04565379: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID19 Pneumonia
Lead sponsor: Shaperon
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
timeFrame: Day 29
Secondary outcomes:
measure: Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline
timeFrame: Day 15 and Day 29
measure: Clinical Status assessed by the six-category ordinal scale at fixed time points
timeFrame: Day 1, 4, 9, 15 and 29
measure: Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours
timeFrame: Up to Day 29
measure: All-cause mortality
timeFrame: Up to Day 29
measure: Duration (days) of mechanical ventilation
timeFrame: Up to Day 29
measure: Duration (days) of extracorporeal membrane oxygenation
timeFrame: Up to Day 29
measure: Duration (days) of supplemental oxygenation
timeFrame: Up to Day 29
measure: Length of hospital stay (days)
timeFrame: Up to Day 29
measure: Length of ICU stay (days)
timeFrame: Up to Day 29
measure: Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups
timeFrame: Day 15 and Day 29
Other outcomes:
measure: Serum level of TNF-α in pg/ml
timeFrame: Day 0, 4, 9, 15 and 29
measure: Serum level of IL-1β in pg/ml
timeFrame: Day 0, 4, 9, 15 and 29
measure: Serum level of IL-6 in pg/ml
timeFrame: Day 0, 4, 9, 15 and 29
measure: Serum level of IL-8 in pg/ml
timeFrame: Day 0, 4, 9, 15 and 29
Locations:
city: Cluj-Napoca
country: Romania
facility: "Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic
city: Craiova
country: Romania
facility: Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults
city: Iaşi
country: Romania
facility: "Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department
city: Ramnicu Sarat
country: Romania
facility: Ramnicu Sarat Clinical Hospital
city: Suceava
country: Romania
facility: "Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department
Study officials:
affiliation: Shaperon Inc.
name: Seung-Yong Seong, Dr.
role: STUDY_CHAIR
References: