Lower respiratory tract infection by Covid-19 at high risk for development of severe respiratory failure 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: Injection
Trade Name: Bactrimel
Product Name: Sulfamethoxazole and Trimethoprim
Pharmaceutical Form: Tablet
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age equal to or above 18 years • Male or female gender • In case of women, unwillingness to remain pregnant during the study period. • Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent • Confirmed infection by SARS-CoV-2 virus • Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection • 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: • Age below 18 years • Denial for written informed consent • Any stage IV malignancy • Any do not resuscitate decision • Presence of respiratory failure • Any primary immunodeficiency • Less than 1,500 neutrophils/mm3 • Known allergy to anakinra • Known allergy to trimethoprim/sulfamehoxazole • Known G-6PD enzyme deficiency • Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone or greater the last 15 days. • Any anti-cytokine biological treatment the last one month • Confirmed pernicious anemia due to folic acid deficiency • Severe hepatic failure • Severe renal failure • Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Recent data coming from the Hellenic Sepsis Study Group reveal that suPAR levels =6 ng/ml are early found among patients who will eventually develop severe respiratory failure (SRF) by Covid-19 with positive predictive value more than 80%. This signifies that an early pro-inflammatory reaction has been started in the lung. It is postulated that early anakinra treatment in these patients may halt this reaction and prevent development of SRF. In the SAVE study patients with sars-cov-2 infection with SARS-CoV-2 virus at high risk for progression to MSDs will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in SAA. ;Secondary Objective: Not applicable;Primary end point(s): This is defined on day 14 as the percentage of patients who will not experience SAIs (as defined in Annex V). Patients who die before the day 14 visit are considered to have failed at the primary endpoint.;Timepoint(s) of evaluation of this end point: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Comparison of the primary endpoint with historical comparators • Change of scoring for respiratory symptoms between days 1 and 7 • Change of scoring for respiratory symptoms between days 1 and 14 • Change of SOFA score between days 1 and 7 • Change of SOFA score between days 1 and 14 • Change of cytokine stimulation between days 1 and 7 • Change of plasma inflammatory mediators between days 1 and 7 • 28-day mortality • 90-day mortality ;Timepoint(s) of evaluation of this end point: Day 7 Day 14 | — |
Countries
Greece
Contacts
Public ContactPresident of the Board
Hellenic Institute for the Study of Sepsis
Outcome results
None listed