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suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19 (SAVE-MORE)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
Hellenic Institute for the Study of Sepsis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV 2, anakinra

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
  • 10th Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
  • 1st Department of Internal Medicine, AMALIA FLEMING Prefecture General Hospital of Melissia
  • 1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
  • 1st Department of Internal Medicine, General Hospital of Eleusis THRIASIO
  • 1st Department of Internal Medicine, General Hospital of Nea Ionia CONSTANTOPOULIO-PATISION
  • 1st Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO
  • 1st University Department of Internal Medicine, General Hospital of Athens LAIKO
  • 1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
  • 2nd Department of Internal Medicine, General Hospital of Eleusis THRIASIO
  • 2nd Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
  • 2nd University Department of Internal Medicine, IPPOKRATEION General Hospital of Athens
  • 3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO-BENAKEIO E.E.S.
  • 3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA
  • 4th Department of Internal Medicine, ATTIKON University General Hospital
  • 4th Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
  • 5th Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
  • COVID-19 Department, General Hospital of Attica SISMANOGLEIO-AMALIA FLEMING
  • Department of Clinical Therapeutics, ALEXANDRA General Hospital of Athens
  • Department of COVID-19, Evangelismos General Hospital
  • Department of Internal Medicine, General Hospital of Athens Elpis
  • • 1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
  • • Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA
  • Department of Pulmonary Medicine, General Hospital of Kerkyra
  • 1st Department of Internal Medicine, General University Hospital of Ioannina
  • Department of Internal Medicine, University General Hospital of Larissa,
  • Department of Internal Medicine, University General Hospital of Patras PANAGIA I VOITHIA
  • 2nd Department of Internal Medicine, General Hospital of Piraeus TZANEIO
  • 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
  • 1st Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki
  • 2nd Department of Propedeutic Medicine, Ippokrateion University General Hospital of Thessaloniki
  • 3rd University Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki
  • Dipartimento di Medicina Dipartimento di Malattie Infettive, ASST Spedali civili
  • Unità Operativa Clinica Malattie Infettive, Ospedale Policlinico San Martino
  • Dipartimento di Medicina Interna, Istituto Clinico Humanitas
  • Medicina Interna, Reumatologia, Immunologia, IRCCS San Raffaele
  • Dipartimento di Malattie Infettive e Tropicali e Microbiologia, IRCCS Ospedale Sacro Cuore Don Calabria
  • Dipartimento di Malattie Infettive ad alta Intensità di cura ed altamente contagiose, IRCCS Lazzaro Spallanzani
  • Dipartimento Scienze di laboratorio e infettivologiche, Policlinico Universitario Agostino Gemelli
  • Dipartimento di Malattie infettive e tropicali-Università dell'Insubria, ASST dei Sette Laghi

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Anakinra

Arm Description

Patients receiving standard-of-care (SOC) and placebo. Placebo is injected subcutaneously once daily for 10 days

Patients receiving SOC and anakinra. Anakinra is injected subcutaneously as 100 mg once daily for 10 days

Outcomes

Primary Outcome Measures

Comparison of the distribution of frequencies of each score of a 5-scale patient state evaluated from the 11-point WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment
Comparison of the distribution of frequencies of each score of the 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. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).

Secondary Outcome Measures

Absolute change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Comparison of the absolute change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Relative change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Comparison of the relative change (%) of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Absolute change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Comparison of the absolute change of the measure of the 11-point of WHO Clinical Progression nordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Relative change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Comparison of the relative (%) change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Absolute change of the SOFA score
Comparison of the absolute change of the SOFA score (in points) between the two arms of treatment
Relative change of the SOFA score
Comparison of the relative (%) change of the SOFA score (in points) between the two arms of treatment
Absolute change of the SOFA score
Comparison of the absolute change of the SOFA score between the two arms of treatment
Relative change of the SOFA score
Comparison of the relative (%) change of the SOFA score between the two arms of treatment
Time until hospital discharge
Comparison of the time until hospital discharge between the two arms of treatment
Time until discharge from the intensive care unit
Comparison of the time until discharge from the intensive care unit between the two arms of treatment
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Relative changes of circulating concentrations of suPAR (μg/liter), D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) by Day 7 from baseline Day 1
Comparison of the relative changes of circulating concentrations of suPAR (μg/liter),D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) between the two arms of treatment
Relative changes of circulating concentrations of C-reactive protein (mg/liter) by Day 7 from baseline Day 1
Comparison of the relative changes of circulating concentrations of C-reactive protein (mg/liter) between the two arms of treatment
Relative changes of circulating concentrations of suPAR (μg/liter),D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) by Day 4 from baseline Day 1
Comparison of the relative changes of circulating concentrations of suPAR (μg/liter),D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) between the two arms of treatment
Relative changes of circulating concentrations of C-reactive protein (mg/liter) by Day 4 from baseline Day 1
Comparison of the relative changes of circulating concentrations of C-reactive protein (mg/liter) between the two arms of treatment
Absolute change of the viral load by Day 7 from baseline Day 1
Comparison of the absolute change of the viral load (in copies) between the two arms of treatment
Relative change of the viral load by Day 7 from baseline Day 1
Comparison of the relative (%) change of the viral load between the two arms of treatment
Absolute change of the viral load by Day 4 from baseline Day 1
Comparison of the absolute change of the viral load (in copies) between the two arms of treatment
relative change of the viral load by Day 4 from baseline Day 1
Comparison of the relative change (%) of the viral load between the two arms of treatment
Transcriptomic analysis
Expression of messenger Ribonucleic Acid (mRNA) will be compared between the two arms of treatment
Proteomic analysis
Protein composition will be compared between the two arms of treatment

Full Information

First Posted
December 18, 2020
Last Updated
September 2, 2022
Sponsor
Hellenic Institute for the Study of Sepsis
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1. Study Identification

Unique Protocol Identification Number
NCT04680949
Brief Title
suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19
Acronym
SAVE-MORE
Official Title
suPAR-Guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE-MORE Double-blind, Randomized, Phase III Confirmatory Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
February 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Institute for the Study of Sepsis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
Since March 2020 when the COVID-19 pandemic started in Europe, the Hellenic Institute for the Study of Sepsis has launched in Greece the SAVE clinical trial (suPAR-guided Anakinra treatment for Validation of the risk and Early management of severe respiratory failure by COVID-19) (EudraCT number 2020-001466-11; approval 38/20 of the National Ethics Committee of Greece, approval IS 028/20 of the National Organization for Medicine of Greece, ClinicalTrials.gov identifier, NCT04357366). The concept of the SAVE trial was that early recognition of the risk for the progression of patients with lower respiratory tract infection (LRTI) by the new coronavirus SARS-CoV-2 into severe respiratory failure (SRF) may guide anakinra therapy to prevent SRF. The tool that was used for the diagnosis of risk for SRF is the biomarker suPAR (soluble urokinase plasminogen activator receptor) at measurable concentrations in the blood ≥6 ng/ml. The trial was designed to be open-label non-randomized and the idea was το the start of treatment well before any sign of respiratory failure emerges. Patients hospitalized at tertiary hospitals during the same time period as the SAVE trial was ongoing and who were receiving the same standard-of-care (SOC) treatment were studied as comparators. An interim analysis was submitted to the National Organization for Medicines; number 108002/23.10/2020. In this interim analysis, 130 patients receiving anakinra treatment and SOC were analysed and they were compared to 130 patients receiving SOC. The 130 SOC parallel comparators were selected by propensity score matching to be fully matched to the anakinra-treated patients for age, comorbidities, severity scores on the day of hospital admission, i.e. APACHE II score, Pneumonia Severity Index (PSI), Sequential Organ Failure Assessment (SOFA) and WHO severity, and for the intake of azithromycin, hydroxychloroquine and dexamethasone. SRF was defined as any respiratory ratio (pO2/FiO2) less than 150 mmHg necessitating mechanical ventilation or non-invasive ventilation (NIV). The results of this analysis may be summarized as follows: The incidence of SRF was significantly decreased from 59.2% in the parallel standard-of-care (SOC) comparators (n= 130) to 22.3% among the 130 anakinra-treated patients; hazard ratio, 0.30; 95% confidence intervals 0.20-0.46; P: 4.6 x 10-8. 30-day mortality was decreased from 22.3% in the SOC comparators to 11.5% among anakinra-treated patients; hazard ratio 0.49; 95% confidence intervals 0.25-0.97%; P: 0.041. Duration of stay at the intensive care unit was shortened with anakinra treatment compared to the SOC comparators for the patients who eventually developed SRF The median cost of hospitalization was significantly reduced from €2.398,40 among SOC comparators to €1.291,40 among anakinra-treated patients No safety concerns were raised.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV 2, anakinra

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind trial
Allocation
Randomized
Enrollment
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receiving standard-of-care (SOC) and placebo. Placebo is injected subcutaneously once daily for 10 days
Arm Title
Anakinra
Arm Type
Experimental
Arm Description
Patients receiving SOC and anakinra. Anakinra is injected subcutaneously as 100 mg once daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Anakinra
Other Intervention Name(s)
Kineret
Intervention Description
Standard-of-care and anakinra. Anakinra is injected subcutaneously as 100 mg once daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Standard-of-care and placebo. Placebo is injected subcutaneously once daily for 10 days
Primary Outcome Measure Information:
Title
Comparison of the distribution of frequencies of each score of a 5-scale patient state evaluated from the 11-point WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment
Description
Comparison of the distribution of frequencies of each score of the 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. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Absolute change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Description
Comparison of the absolute change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Time Frame
28 days
Title
Relative change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Description
Comparison of the relative change (%) of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Time Frame
28 days
Title
Absolute change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Description
Comparison of the absolute change of the measure of the 11-point of WHO Clinical Progression nordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Time Frame
14 days
Title
Relative change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS)
Description
Comparison of the relative (%) change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment. The scale ranges from 0 (best outcome-asymptomatic) to 11 (worst outcome-death).
Time Frame
14 days
Title
Absolute change of the SOFA score
Description
Comparison of the absolute change of the SOFA score (in points) between the two arms of treatment
Time Frame
14 days
Title
Relative change of the SOFA score
Description
Comparison of the relative (%) change of the SOFA score (in points) between the two arms of treatment
Time Frame
14 days
Title
Absolute change of the SOFA score
Description
Comparison of the absolute change of the SOFA score between the two arms of treatment
Time Frame
7 days
Title
Relative change of the SOFA score
Description
Comparison of the relative (%) change of the SOFA score between the two arms of treatment
Time Frame
7 days
Title
Time until hospital discharge
Description
Comparison of the time until hospital discharge between the two arms of treatment
Time Frame
90 days
Title
Time until discharge from the intensive care unit
Description
Comparison of the time until discharge from the intensive care unit between the two arms of treatment
Time Frame
90 days
Title
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Description
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Time Frame
90 days
Title
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Description
Comparison of the rate of serious and non-serious adverse events between the two arms of treatment
Time Frame
60 days
Title
Relative changes of circulating concentrations of suPAR (μg/liter), D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) by Day 7 from baseline Day 1
Description
Comparison of the relative changes of circulating concentrations of suPAR (μg/liter),D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) between the two arms of treatment
Time Frame
7 days
Title
Relative changes of circulating concentrations of C-reactive protein (mg/liter) by Day 7 from baseline Day 1
Description
Comparison of the relative changes of circulating concentrations of C-reactive protein (mg/liter) between the two arms of treatment
Time Frame
7 days
Title
Relative changes of circulating concentrations of suPAR (μg/liter),D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) by Day 4 from baseline Day 1
Description
Comparison of the relative changes of circulating concentrations of suPAR (μg/liter),D-dimers (μg/liter), ferritin (μg/liter), and Interleukin-6 (μg/liter) between the two arms of treatment
Time Frame
4 days
Title
Relative changes of circulating concentrations of C-reactive protein (mg/liter) by Day 4 from baseline Day 1
Description
Comparison of the relative changes of circulating concentrations of C-reactive protein (mg/liter) between the two arms of treatment
Time Frame
4 days
Title
Absolute change of the viral load by Day 7 from baseline Day 1
Description
Comparison of the absolute change of the viral load (in copies) between the two arms of treatment
Time Frame
7 days
Title
Relative change of the viral load by Day 7 from baseline Day 1
Description
Comparison of the relative (%) change of the viral load between the two arms of treatment
Time Frame
7 days
Title
Absolute change of the viral load by Day 4 from baseline Day 1
Description
Comparison of the absolute change of the viral load (in copies) between the two arms of treatment
Time Frame
4 days
Title
relative change of the viral load by Day 4 from baseline Day 1
Description
Comparison of the relative change (%) of the viral load between the two arms of treatment
Time Frame
4 days
Title
Transcriptomic analysis
Description
Expression of messenger Ribonucleic Acid (mRNA) will be compared between the two arms of treatment
Time Frame
7 days
Title
Proteomic analysis
Description
Protein composition will be compared between the two arms of treatment
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Cost of hospitalization
Description
Comparison of the cost of hospitalization between the two arms of treatment
Time Frame
90 days
Title
Comparison of the distribution of frequencies of each score of a 5-scale patient state
Description
Comparison of the distribution of frequencies of each score of the 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 60. The scale ranges from 0 (best outcome outpatients) to 5 (worst outcome-death)
Time Frame
60 days
Title
Comparison of the distribution of frequencies of each score of a 5-scale patient state
Description
Comparison of the distribution of frequencies of each score of the 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 90. The scale ranges from ) (best outcome-outpatients) to 5 (worst outcome-death)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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. Confirmed infection by SARS-CoV-2 virus Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelos Giamarellos-Bourboulis, MD, PhD
Organizational Affiliation
Hellenic Institute for the Study of Sepsis
Official's Role
Study Chair
Facility Information:
Facility Name
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
City
Alexandroupolis
Country
Greece
Facility Name
10th Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
City
Athens
Country
Greece
Facility Name
1st Department of Internal Medicine, AMALIA FLEMING Prefecture General Hospital of Melissia
City
Athens
Country
Greece
Facility Name
1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
City
Athens
Country
Greece
Facility Name
1st Department of Internal Medicine, General Hospital of Eleusis THRIASIO
City
Athens
Country
Greece
Facility Name
1st Department of Internal Medicine, General Hospital of Nea Ionia CONSTANTOPOULIO-PATISION
City
Athens
Country
Greece
Facility Name
1st Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO
City
Athens
Country
Greece
Facility Name
1st University Department of Internal Medicine, General Hospital of Athens LAIKO
City
Athens
Country
Greece
Facility Name
1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
City
Athens
Country
Greece
Facility Name
2nd Department of Internal Medicine, General Hospital of Eleusis THRIASIO
City
Athens
Country
Greece
Facility Name
2nd Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
City
Athens
Country
Greece
Facility Name
2nd University Department of Internal Medicine, IPPOKRATEION General Hospital of Athens
City
Athens
Country
Greece
Facility Name
3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO-BENAKEIO E.E.S.
City
Athens
Country
Greece
Facility Name
3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA
City
Athens
Country
Greece
Facility Name
4th Department of Internal Medicine, ATTIKON University General Hospital
City
Athens
Country
Greece
Facility Name
4th Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
City
Athens
Country
Greece
Facility Name
5th Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
City
Athens
Country
Greece
Facility Name
COVID-19 Department, General Hospital of Attica SISMANOGLEIO-AMALIA FLEMING
City
Athens
Country
Greece
Facility Name
Department of Clinical Therapeutics, ALEXANDRA General Hospital of Athens
City
Athens
Country
Greece
Facility Name
Department of COVID-19, Evangelismos General Hospital
City
Athens
Country
Greece
Facility Name
Department of Internal Medicine, General Hospital of Athens Elpis
City
Athens
Country
Greece
Facility Name
• 1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
City
Athens
Country
Greece
Facility Name
• Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA
City
Athens
Country
Greece
Facility Name
Department of Pulmonary Medicine, General Hospital of Kerkyra
City
Corfu
Country
Greece
Facility Name
1st Department of Internal Medicine, General University Hospital of Ioannina
City
Ioánnina
Country
Greece
Facility Name
Department of Internal Medicine, University General Hospital of Larissa,
City
Larissa
Country
Greece
Facility Name
Department of Internal Medicine, University General Hospital of Patras PANAGIA I VOITHIA
City
Patra
Country
Greece
Facility Name
2nd Department of Internal Medicine, General Hospital of Piraeus TZANEIO
City
Piraeus
Country
Greece
Facility Name
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Facility Name
1st Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Facility Name
2nd Department of Propedeutic Medicine, Ippokrateion University General Hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Facility Name
3rd University Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Facility Name
Dipartimento di Medicina Dipartimento di Malattie Infettive, ASST Spedali civili
City
Brescia
Country
Italy
Facility Name
Unità Operativa Clinica Malattie Infettive, Ospedale Policlinico San Martino
City
Genova
Country
Italy
Facility Name
Dipartimento di Medicina Interna, Istituto Clinico Humanitas
City
Milano
Country
Italy
Facility Name
Medicina Interna, Reumatologia, Immunologia, IRCCS San Raffaele
City
Milano
Country
Italy
Facility Name
Dipartimento di Malattie Infettive e Tropicali e Microbiologia, IRCCS Ospedale Sacro Cuore Don Calabria
City
Negrar
Country
Italy
Facility Name
Dipartimento di Malattie Infettive ad alta Intensità di cura ed altamente contagiose, IRCCS Lazzaro Spallanzani
City
Roma
Country
Italy
Facility Name
Dipartimento Scienze di laboratorio e infettivologiche, Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Facility Name
Dipartimento di Malattie infettive e tropicali-Università dell'Insubria, ASST dei Sette Laghi
City
Varese
Country
Italy

12. IPD Sharing Statement

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

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