A study investigating the efficacy and safety of 2 doses of NuSepin® intravenous infusion in adult subjects with Covid-19 pneumonia

Phase 1

• Conditions: Adult subjects with Covid-19 pneumonia; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-003107-34-RO
• Lead Sponsor: Shaperon Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-09
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female subjects =18 years and < 80 years.
2. Laboratory-confirmed SARS-CoV-2 infection by PCR for the
first time within 72 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified