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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04565379
Other study ID # Shaperon001
Secondary ID 2020-003107-34
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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