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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2021-04-13

Brief Summary

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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

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Detailed Description

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Conditions

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COVID19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NuSepin® 0.1 mg

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

Group Type ACTIVE_COMPARATOR

NuSepin® 0.1 mg

Intervention Type DRUG

NuSepin® 0.1 mg

NuSepin® 0.2 mg

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

Group Type ACTIVE_COMPARATOR

NuSepin® 0.2 mg

Intervention Type DRUG

NuSepin® 0.2 mg

Placebo

100 ml normal saline infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal Saline

Interventions

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NuSepin® 0.1 mg

Intervention Type DRUG

NuSepin® 0.2 mg

Intervention Type DRUG

Placebo

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No