COVID-19 MedDRA version: 20.0 Level: LLT Classification code 10035738 Term: Pneumonia viral NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Kineret
Product Name: Anakinra
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for solution for injection
Route of administra
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age equal to or above 18 years 2. Male or female gender 3. In case of women, unwillingness to remain pregnant during the study period. 4. Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation in the Member State where the trial is planned. 5. Confirmed infection by SARS-CoV-2 virus 6. Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection 7. Need for hospitalization for COVID-19. The need for hospitalization is defined by the attending physician taking into consideration clinical presentation, requirement for supportive care, potential risk factors for severe disease, and conditions at home, including the presence of vulnerable persons in the household. 8. Plasma suPAR =6ng/ml 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: • Age below 18 years • Denial for written informed consent • Any stage IV malignancy • Any do not resuscitate decision • ?ny pO2/FiO2 (partial oxygen pressure to fraction of inspired oxygen) ratio less than 150 mmHg irrespective if the patient is under mechanical ventilation (MV) / non-invasive ventilation (NIV) / extracorporeal membrane oxygenation (ECMO) or not • Patient under MV or NIV or ECMO • Any primary immunodeficiency • Less than 1,500 neutrophils/mm3 • Plasma suPAR less than 6 ng/ml • Known hypersensitivity to anakinra • Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days. • Any anti-cytokine biological treatment the last one month • Severe hepatic failure defined as Child-Pugh stage of 3 • End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis • Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study • Participation in any other interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The SAVE-MORE is a pivotal, confirmatory, phase III randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days as measured by the ordinal scale of the 11-point WHO clinical progression scale (CPS).;Secondary Objective: Not applicable;Primary end point(s): The primary study outcome is the comparative 5-scale patient state evaluated from the 11-point WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment by Day 28. This will be expressed as the distribution of the frequencies of each score of the scale in each arm of treatment by Day 28.;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The comparison of the following between the two arms of treatment: • Change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) by Day 28 from baseline Day 1 (both absolute and relative changes) • Change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) by Day 14 from baseline Day 1 (both absolute and relative changes) • Change of the SOFA score by Day 14 from baseline Day 1 (both absolute and relative changes) • Change of the SOFA score by Day 7 from baseline Day 1 (both absolute and relative changes) • Time until discharge from hospital • Time until discharge from the intensive care unit (this applies only for patients failing the primary outcome who will be admitted in the ICU) • Long-term safety by Day 60 • Long-term safety by Day 90 • Relative changes of circulating concentrations of suPAR, CRP, D-dimers, ferritin, and IL-6 by Day 7 from baseline Day 1 • Relative changes of circulating concentrations of suPAR, CRP, D-dimers, ferritin, and IL-6 by Day 4 from baseline Day 1 • Change of the viral load by Day 7 from baseline Day 1 (both absolute and relative changes) • Change of the viral load by Day 4 from baseline Day 1 (both absolute and relative changes) • Transcriptomic analysis that will also allow for lymphocyte cell subset analysis • Proteomic analyses • Relation of endpoints to duration of disease (from first symptoms) and timing of treatment initiation;Timepoint(s) of evaluation of this end point: Days 4, 7, 14, 28, 60 and 90, at hospital discharge and at discharge from the intensive care unit | — |
Countries
Greece
Contacts
Public ContactPresident of the Board
Hellenic Institute for the Study of Sepsis
Outcome results
None listed