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

Shaperon

Status and phase: Completed; Phase 2

Conditions: COVID19 Pneumonia

Treatments: Drug: NuSepin® 0.2 mg; Drug: Placebo; Drug: NuSepin® 0.1 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04565379

Shaperon001

2020-003107-34 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups, including a placebo group

NuSepin® 0.1 mg

Active Comparator group

Description:

NuSepin® 0.1 mg/kg in 100 ml normal saline infusion

Treatment:

Drug: NuSepin® 0.1 mg

NuSepin® 0.2 mg

Active Comparator group

Description:

NuSepin® 0.2 mg/kg in 100 ml normal saline infusion

Treatment:

Drug: NuSepin® 0.2 mg

Placebo

Placebo Comparator group

Description:

100 ml normal saline infusion

Treatment:

Drug: Placebo