suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE)

• Status: Recruiting
• Trial end date: 2022-04-15
• Target enrollment: 0
• Participant gender: All

Summary

In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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 using molecular techniques as defined by the World Health Organization

• Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection

• Plasma suPAR ≥6ng/ml

Exclusion Criteria:

• Age below 18 years

• Denial for written informed consent

• Any stage IV malignancy

• Any do not resuscitate decision

• Any primary immunodeficiency

• Less than 1,500 neutrophils/mm3

• Known hypersensitivity to anakinra

• Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone for a greater period than the last 15 days.

• Any anti-cytokine biological treatment the last one month

• Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study

• Severe hepatic failure

• Severe renal failure

• Any need for CPAP or mechanical ventilation

• Any pO2/FiO2 ratio less than 150