COVID-19 Pneumonia Patients MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Sponsors
Shaperon, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) An individual who has fully informed of all pertinent aspect of the trial and IMP, voluntarily decided to participate in the trial and adherence to the trial-related requirements, and provided a written informed consent 2) An adult man or woman aged 19 years (or age of majority in his/her country) and older. 3) A hospitalized patient with laboratory-confirmed SARS-CoV-2 infection by PCR test within 10 days (240 hours) prior to randomization. 4) At the time of randomization; and whose clinical status is stage 4 (oxygenation by facial mask or nasal cannula) or 5 (non-invasive ventilation or high flow oxygen) on WHO 8-point ordinal scale 5) Pneumonia that satisfies all the following criteria at the time of randomization (1) Confirmation of Lung infiltration (chest x-ray, CT, etc. within 48 hours before randomization) (2) Patients with SpO2=94% at room air condition or on oxigen therapy 6) Planned first dosing of the IMP not later than 2 days after the initiation of standard of care (SOC), when given in combination with SOC for severe Illness (according to NIH Clinical Spectrum of SARS-CoV-2 Infection) 7) A score of 5 points or more (“think sepsis”) on the NEWS 2 scale at the time of randomization 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 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 334
Exclusion criteria
Exclusion criteria: 1) A patient whose clinical status is stage 3 or lower on the WHO 8-point ordinal scale (WHO 8-OS) at the time of randomization 2) An individual who requires endotracheal intubation, mechanical ventilation (WHO 8-OS stage 6), or extracorporeal membrane oxygen therapy (stage 7) at the time of randomization 3) A patient with multiorgan failure, shock, acute respiratory syndrome (ARDS) 4) A patient with renal dysfunction defined by eGFR less than 30mL/min/1.73m², or the use of hemodialysis or hemofiltration 5) Cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction 6) Any of the following laboratory test results at the time of screening: (1) Alanine aminotransferase (ALT) exceeding the upper normal limit (UNL) by 5 times (2) Aspartate aminotransferase (AST) exceeding the upper normal limit (UNL) by 5 times (3) Total bilirubin exceeding the upper normal limit by 3 times 7) An individual with HIV-positive results or who requires antiviral treatments against active hepatitis (HBV, HCV) 8) A patient with any of following infectious diseases (e.g., active tuberculosis, etc.) in the past or at present (2) A patient is diagnosed to have a respiratory viral or bacterial infection including active tuberculosis and excluding SARS-CoV-2 within 14 days prior to screening (However, those who have initially received a systemic antiinfective therapy based on clinical suspicion of a non-SARSCoV-2 infectious disease are allowed to participate in the trial, only when definitive diagnosis of SARS-CoV-2 infection is made.) 9) A patient who uses mechanical ventilation (invasive or non-invasive) or oxygen therapy due to chronic lung diseases or neuromuscular disorders 10) A patient who requires oxygen therapy due to lung diseases other than COVID-19 pneumonia (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, cystic pulmonary disease, etc.), congestive heart failure (NYHA Class 3 or 4), pulmonary edema, etc. 11) An individual with a past medical history of hypersensitivity to the IMP and the standard therapies (Remdesivir, etc.) as well as to any ingredients of such drugs 12) An individual who has received any of the prohibited medications within the protocol-specified timeframes of enrollment in the clinical trial (e.g., live vaccines within 4 weeks of screening) 13) A woman with childbearing potential who has tested positive in the pregnancy test performed before participating in the clinical trial 14) Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP not agreeing to ? use a highly effective method of contraception (hormonal contraceptives, intrauterine device (IUD), intrauterine system (IUS), vasectomy, intubation ligation, etc.); or use a double barrier method of contraception if the highly effective method is not possible (A combination between male condoms, female condoms, cervical caps, contraceptive diaphragms, and contraceptive sponges) during the course of the trial (until EOS visit); or ? donate the sperm until one month after the completion of the trial. 15) A patient who is expected to be discharged or transferred within 72 hours 16) A patient with less than 24 hours of life expectancy 17) An individual who is currently participating in another clinical trial, or who received other study drugs as part of another clinical study within 2 months before the first dosing of the IMP (Th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the dose and dosage for intravenous administration to be applied in the NuSepin® phase 3 clinical trial by measuring the time to a 2-point reduction on the WHO 8-point ordinal scale. [Phase 2b] 2. To examine superiority of intravenous administration of NuSepin® compared to placebo in hospitalized patients with COVID-19 pneumonia by measuring the time to discharge [Phase 3];Secondary Objective: To evaluate the effect of intravenous NuSepin® administration on - the improvement of clinical status compared to the control group - the improvement of illness severity over time based on vital signs (NEWS2) compared to the control group. - the use of oxygen ventilatory assistance (facial mask, low-flow oxygen cannula, high-flow oxygen cannula, Non-invasive ventilation, Invasive Mechanical Ventilation/ECMO) compared to the control group. - a shortening of hospitalization (ICU) period compared to the control group. - the survival compared to the control group. - the inflammatory markers compared to the control group - the improvement of cytokine release syndrome compared to the control group. - the viral burden compared to the control group. To evaluate drug compliance of intravenous administration of NuSepin® To evaluate the overall safety of NuSepin®;Primary end point(s): - Time to improvement of at least 2 categories relative to the first dosing date of the IMP (randomization date*) on an 8-point ordinal scale (WHO 8-OS) of clinical status up to day 29 [Phase 2b] - Time to discharge, relative to the first dosing date of the IMP (randomization date*) [Phase 3];Timepoint(s) of evaluation of this end point: - Every day from Day 2 to Day 14 during hospitalization period - Day 15 (EOT) - Day 29 (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Endpoints related to WHO 8-point ordinal scale 1) The proportion of subjects with categories of 2 or less (outpatient condition); and 3 or less (hospitalized, no oxygen treatment) at day 8, 15 and 29 2) The proportion of subjects with a decrease (improvement) of at least 2 categories on day 8, 15 and 29 3) Time to clinical recovery (categories of 1 or less according to WHO 8-OS) 4) Time to clinical improvement (a decrease (improvement) of at least 2 categories) on an 8-point ordinal scale (WHO 8-OS) of clinical status (only for phase 3) 5) Time to discharge relative to the first dosing date of the IMP (randomization date) (only for phase 2) Endpoints related to NEWS 2 6) Time to normalization of vital signs that lasts 24 hours or more (score 0 on NEWS2 that lasts 24 hours or more) 7) The proportion of subjects with a NEWS2 of 0 on day 8, 15 and 29 8) The proportion of subjects with a NEWS2 of 2 or less on day 8, 15 and 29 9) The proportion of subjects with a decrease of at least 2 points relative to baseline on a NEWS2 at days 8, 15, and 29 10) The proportion of subjects with a decrease by at least 15% relative to baseline on a NEWS2 at day 8, 15, and 29 11) The proportion of subjects with a decrease by at least 30% relative to baseline on a NEWS2 at day 8, 15, and 29 12) The proportion of subjects with a decrease by at least 60% relative to baseline on a NEWS2 at day 8, 15, and 29 Endpoints related to the use of ventilatory assistance 13) The proportion of subjects undergoing a ventilatory assistance (facial mask, low-flow oxygen cannula, high-flow oxygen cannula, Non-invasive ventilation, Invasive Mechanical Ventilation/ECMO) at day 8, day 15, and day 29; and the days of each ventilatory assistance since the first dosing date of IMP (randomization date) up to day 29 Endpoints related to Hospitalization and ICU Admission 14) Proportion of subjects transferred to ICU and the duration of ICU admission (date of admission to ICU ~ d | — |
Countries
Bosnia and Herzegovina, Bulgaria, Croatia, Korea, Republic of, North Macedonia, Romania, Serbia, Slovakia
Contacts
Public ContactMatyas Petho
HungaroTrial Zrt.
Outcome results
None listed