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

Study Overview
=================
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

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

Conditions
-----------------
COVID19 Pneumonia

Intervention / Treatment
-----------------
* Drug: NuSepin® 0.1 mg
* Drug: NuSepin® 0.2 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or female subjects aged between 18≤ and <80 years old Laboratory-confirmed SARS-CoV-2 infection by PCR test for the first time within 144 hours prior to randomization 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 Patients with blood leukocyte count > 4.0 x 109 /L and lymphocyte count > 0.7 x 109 L Patients with SpO2 ≤ 94% on room air or Pa02/FI02 ratio < 300mgHg at screening Patients capable to give consent and who have signed the informed consent form before any trial related assessment. 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. Patients with NEWS2 score > 7 Exclusion Criteria Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal. Reduced renal function with estimated glomerular filtration rate (eGFR) < 30 ml/min or hemodialysis or hemofiltration. Pregnancy or breast feeding. Evidence of multiorgan failure Steroid treatment by any reason within 72 hours prior to enrolment Participation in any other clinical trial of an experimental agent treatment for COVID-19 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NuSepin® 0.1 mg<br>NuSepin® 0.1 mg/kg in 100 ml normal saline infusion | Drug: NuSepin® 0.1 mg<br>* NuSepin® 0.1 mg<br>|
| Active Comparator: NuSepin® 0.2 mg<br>NuSepin® 0.2 mg/kg in 100 ml normal saline infusion | Drug: NuSepin® 0.2 mg<br>* NuSepin® 0.2 mg<br>|
| Placebo Comparator: Placebo<br>100 ml normal saline infusion | Drug: Placebo<br>* Normal Saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days) |  | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline |  | Day 15 and Day 29 | 
| 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 | 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 |  | Up to Day 29 | 
| All-cause mortality |  | Up to Day 29 | 
| Duration (days) of mechanical ventilation |  | Up to Day 29 | 
| Duration (days) of extracorporeal membrane oxygenation |  | Up to Day 29 | 
| Duration (days) of supplemental oxygenation |  | Up to Day 29 | 
| Length of hospital stay (days) |  | Up to Day 29 | 
| Length of ICU stay (days) |  | Up to Day 29 | 
| Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups |  | Day 15 and Day 29 |