COVID19 Pneumonia
Conditions
Brief 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
Interventions
DRUGNuSepin® 0.1 mg
NuSepin® 0.1 mg
DRUGNuSepin® 0.2 mg
NuSepin® 0.2 mg
DRUGPlacebo
Normal Saline
Sponsors
Shaperon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days) | Day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | Up to Day 29 | — |
| Duration (days) of supplemental oxygenation | Up to Day 29 | — |
| Length of hospital stay (days) | Up to Day 29 | — |
| Length of ICU stay (days) | Up to Day 29 | — |
| Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups | Day 15 and Day 29 | — |
| Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline | Day 15 and Day 29 | — |
| Clinical Status assessed by the six-category ordinal scale at fixed time points | Day 1, 4, 9, 15 and 29 | Minimum value being 1, Maximum value being 6. Smaller the number, better the clinical status & outcome |
| Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours | Up to Day 29 | — |
| Duration (days) of mechanical ventilation | Up to Day 29 | — |
| Duration (days) of extracorporeal membrane oxygenation | Up to Day 29 | — |
Other
| Measure | Time frame |
|---|---|
| Serum level of IL-6 in pg/ml | Day 0, 4, 9, 15 and 29 |
| Serum level of IL-8 in pg/ml | Day 0, 4, 9, 15 and 29 |
| Serum level of IL-1β in pg/ml | Day 0, 4, 9, 15 and 29 |
| Serum level of TNF-α in pg/ml | Day 0, 4, 9, 15 and 29 |
Countries
Romania
Outcome results
None listed