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

COVID19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565379
• Other study ID #: Shaperon001
• Secondary ID: 2020-003107-34
• Status: Completed
• Phase: Phase 2
• Start date: September 24, 2020
• Est. completion date: April 13, 2021

Study information

• Verified date: January 2022
• Source: Shaperon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID19 Pneumonia
• Pneumonia

Intervention

Drug:
• NuSepin® 0.1 mg
NuSepin® 0.1 mg
• NuSepin® 0.2 mg
NuSepin® 0.2 mg
• Placebo
Normal Saline

Locations

Country	Name	City	State
Romania	"Leon Daniello" Clinical Hospital of Pneumophtisiology Cluj-Napoca Pneumology Clinic	Cluj-Napoca
Romania	Clinical Hospital for Infectious Diseases and Pneumophtisiology "Victor Babes", Craiova Infectious Diseases Clinic for Adults	Craiova
Romania	"Sf. Parascheva" Infectious Diseases Clinical Hospital Iasi Infectious Diseases Department	Iasi
Romania	Ramnicu Sarat Clinical Hospital	Ramnicu Sarat
Romania	"Sf. Ioan cel Nou" Suceava County Emergency Hospital Infectious Diseases Department	Suceava

Sponsors (1)

Lead Sponsor	Collaborator
Shaperon

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum level of TNF-a in pg/ml		Day 0, 4, 9, 15 and 29
Other	Serum level of IL-1ß in pg/ml		Day 0, 4, 9, 15 and 29
Other	Serum level of IL-6 in pg/ml		Day 0, 4, 9, 15 and 29
Other	Serum level of IL-8 in pg/ml		Day 0, 4, 9, 15 and 29
Primary	Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)		Day 29
Secondary	Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline		Day 15 and Day 29
Secondary	Clinical Status assessed by the six-category ordinal scale at fixed time points	Minimum value being 1, Maximum value being 6. Smaller the number, better the clinical status & outcome	Day 1, 4, 9, 15 and 29
Secondary	Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of = 2 maintained for 24 hours		Up to Day 29
Secondary	All-cause mortality		Up to Day 29
Secondary	Duration (days) of mechanical ventilation		Up to Day 29
Secondary	Duration (days) of extracorporeal membrane oxygenation		Up to Day 29
Secondary	Duration (days) of supplemental oxygenation		Up to Day 29
Secondary	Length of hospital stay (days)		Up to Day 29
Secondary	Length of ICU stay (days)		Up to Day 29
Secondary	Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups		Day 15 and Day 29