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

• Status: Recruiting
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaperon

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.