suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19

• Status: Active, not recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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 World Health Organization (WHO) clinical progression scale (CPS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis
• Treatments: Interleukin 1 Receptor Antagonist Protein

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

Exclusion Criteria:

• Age below 18 years

• Denial for written informed consent

• Any stage IV malignancy

• Any do not resuscitate decision

• Αny 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