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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
"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
Iași, Romania
Ramnicu Sarat Clinical Hospital
Râmnicu Sărat, Romania
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
Time frame: Day 29
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
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
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
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"Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department
Suceava, Romania
Time frame: Day 15 and Day 29