Status:
COMPLETED
suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE)
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
COVID-19
Virus Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The major hurdle of Coronavirus disease 2019 (COVID-19) is the early recognition of the patients at high risk for the development of severe respiratory failure (SRF). If this can be achieved early, th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04357366
Start Date
April 15 2020
End Date
April 15 2022
Last Update
July 13 2023
Active Locations (28)
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1
COVID-19 Department, General Hospital of Attica SISMANOGLEIO-AMALIA FLEMING
Marousi, Athens, Greece, 15126
2
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
3
Department of Internal Medicine, I PAMMAKARISTOS Hospital
Athens, Greece, 11144
4
1st Department of InternalMedicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
Athens, Greece, 11526