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

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.