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AnakinraWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (28)


Name (Synonyms) Correlation
drug1037 trimethoprim/sulfamethoxazole Wiki 0.38
drug794 Streptokinase Wiki 0.38
drug309 Five-days oseltamivir Wiki 0.38
drug311 Fixed-duration higher dose Hydrocortisone Wiki 0.38
drug491 Macrolide administered for 3-5 days Wiki 0.38
drug831 Ten-days oseltamivir Wiki 0.38
drug178 Ceftaroline Wiki 0.38
drug366 Hydroxychloroquine + lopinavir/ritonavir Wiki 0.38
drug567 Normal saline Wiki 0.38
drug518 Moxifloxacin or Levofloxacin Wiki 0.38
drug492 Macrolide administered for up to 14 days Wiki 0.38
drug310 Fixed-duration Hydrocortisone Wiki 0.38
drug352 Huaier Granule Wiki 0.38
drug879 Unfractionated heparin Wiki 0.38
drug433 Interferon-β1a Wiki 0.38
drug281 Emapalumab Wiki 0.38
drug747 Shock-dependent hydrocortisone Wiki 0.38
drug179 Ceftriaxone Wiki 0.38
drug45 Amoxicillin-clavulanate Wiki 0.38
drug615 Piperacillin-tazobactam Wiki 0.38
drug854 Tocilizumab Wiki 0.28
drug552 Nitric Oxide Wiki 0.27
drug748 Siltuximab Wiki 0.27
drug230 Convalescent plasma Wiki 0.19
drug883 Usual Care Wiki 0.19
drug732 Sarilumab Wiki 0.15
drug478 Lopinavir/ritonavir Wiki 0.12
drug360 Hydroxychloroquine Wiki 0.05

Correlated MeSH Terms (13)


Name (Synonyms) Correlation
D055501 Macrophage Activation Syndrome NIH 0.38
D045169 Severe Acute Respiratory Syndrome NIH 0.13
D007239 Infection NIH 0.13
D014777 Virus Diseases NIH 0.12
D055371 Acute Lung Injury NIH 0.12
D012127 Respiratory Distress Syndrome, Newborn NIH 0.12
D018352 Coronavirus Infections NIH 0.11
D012128 Respiratory Distress Syndrome, Adult NIH 0.10
D012141 Respiratory Tract Infections NIH 0.10
D003141 Communicable Diseases NIH 0.09
D011024 Pneumonia, Viral NIH 0.06
D013577 Syndrome NIH 0.06
D011014 Pneumonia NIH 0.03

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There are 7 clinical trials

Clinical Trials


1 Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome ofon patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.

NCT02735707 Community-acquired Pneumonia, Influenza, COVID-19 Drug: Fixed-duration Hydrocortisone Drug: Shock-dependent hydrocortisone Drug: Ceftriaxone Drug: Moxifloxacin or Levofloxacin Drug: Piperacillin-tazobactam Drug: Ceftaroline Drug: Amoxicillin-clavulanate Drug: Macrolide administered for 3-5 days Drug: Macrolide administered for up to 14 days Drug: Five-days oseltamivir Drug: Ten-days oseltamivir Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: Hydroxychloroquine + lopinavir/ritonavir Drug: Interferon-β1a Drug: Anakinra Drug: Fixed-duration higher dose Hydrocortisone Drug: Tocilizumab Drug: Sarilumab
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: All-cause mortality

Time: Day 90

Description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection

Measure: Days alive and outside of ICU

Time: Day 21

Secondary Outcomes

Measure: ICU Mortality

Time: Day 90

Measure: ICU length of stay

Time: Day 90

Measure: Hospital length of stay

Time: Day 90

Measure: Ventilator free days

Time: Day 28

Measure: Organ failure free days

Time: Day 28

Measure: All-cause mortality

Time: 6 months

Description: EQ5D-5L and WHODAS 2.0 (not completed in all regions)

Measure: Health-related Quality of life assessment

Time: 6 months

Measure: Proportion of intubated patients who receive a tracheostomy

Time: Day 28

Description: Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital

Measure: Destination at time of hospital discharge

Time: Free text Day 90

Measure: Readmission to the index ICU during the index hospitalization

Time: Day 90

Measure: World Health Organisation 8-point ordinal scale outcome

Time: Hospital discharge

Other Outcomes

Description: Antibiotic Domain specific outcome

Measure: Occurrence of multi-resistant organism colonisation/infection

Time: Day 90, censored at hospital discharge

Description: Antibiotic Domain specific outcome

Measure: Occurrence clostridium difficile

Time: Day 90, censored at hospital discharge

Description: Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome.

Measure: Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death

Time: Day 90, censored at hospital discharge

Description: Antiviral Domain specific outcome. Only required at selected sites.

Measure: Change from baseline influenza virus levels in upper and lower respiratory tract specimens

Time: Day 3, up to Day 7

Description: COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint

Measure: Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing)

Time: Day 90, censored at hospital discharge

2 A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.

As shown by the data available, hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system to the presence of the virus, is considered to represent one of the most important negative prognostic factor in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The objective of this study is to investigate new possibilities to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.

NCT04324021 SARS-CoV-2 Biological: Emapalumab Biological: Anakinra
MeSH:Infection

Primary Outcomes

Description: Defined as the proportion of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)

Measure: Treatment success

Time: Up to Day 15

Secondary Outcomes

Description: Measured in days

Measure: Time to mechanical ventilation

Time: Date of randomization to date of mechanical ventilation

Description: Measured in total score

Measure: Change from baseline in Modified Early Warning system score

Time: Baseline, Day 15

Description: Measured in percent (%)

Measure: Change from baseline in resting peripheral capillary oxygen saturation (SpO2)

Time: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15

Description: Measured in percent (%)

Measure: Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2)

Time: Baseline, Day 15

Description: Measured in local units

Measure: Change of pH in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of oxygen tension (pO2) in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of potassium in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of sodium in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of chloride in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of lactic acid in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change of hemoglobin in hemogasanalysis from baseline

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in l/min

Measure: Change from baseline in oxygen supplementation

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done

Measure: Change of findings of high-resolution computed tomography (CT) scan of the chest

Time: Screening, Day 15

Description: Measured in local units

Measure: Change from baseline in Ferritin

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in lactate dehydrogenase (LDH)

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in D-dimers

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in White Blood Cells with differential counts

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Red Blood Counts

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Hemoglobin

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Platelet count

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Fibrinogen

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Complement factors C3/C4

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Prothrombin time

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Cardiac troponin

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in aspartate aminotransferase (AST)

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in alanine aminotransferase (ALT)

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in total bilirubin levels

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in C-Reactive Protein

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Measured in local units

Measure: Change from baseline in Creatinine

Time: Baseline, Days 4, 7, 10, 13 and 15

Description: Confirmation of death

Measure: Overall survival

Time: Weeks 6 and 10

Description: Measured in days

Measure: Time to hospital discharge

Time: Weeks 6 and 10

3 A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome

The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome

NCT04330638 COVID-19 Other: Usual Care Drug: Anakinra Drug: Siltuximab Drug: Tocilizumab

Primary Outcomes

Description: defined as the time from randomization to either an improvement of two points on a six-category ordinal scale or discharge from the hospital: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: Time to Clinical Improvement

Time: at day 15

Secondary Outcomes

Description: defined as independece from supplemental oxygen

Measure: Time to improvement in oxygenation

Time: during hospital admission (up to 28 days)

Description: defined by Pa02/FiO2 ratio while breading room air

Measure: Mean change in oxygenation

Time: day 1, day 15 or hospital discharge, whichever is first

Measure: Number of days with hypoxia

Time: during hospital admission (up to 28 days)

Measure: Number of days of supplemental oxygen use

Time: during hospital admission (up to 28 days)

Measure: Time to absence fever for more than 48h without antipyretics

Time: during hospital admission (up to 28 days)

Measure: Number of days with fever

Time: during hospital admission (up to 28 days)

Measure: Time to halving of CRP levels compared to peak value during trial

Time: during hospital admission (up to 28 days)

Measure: Time to halving of ferritin levels compared to peak value during trial

Time: during hospital admission (up to 28 days)

Measure: Incidence of AEs (Adverse Events)

Time: during hospital admission (up to 28 days)

Measure: Incidence of SAEs (Serious Adverse Events)

Time: during hospital admission (up to 28 days)

Measure: Duration of hospital stay

Time: during hospital admission (up to 28 days)

Measure: Duration of hospital stay in survivors

Time: during hospital admission (up to 28 days)

Description: Clinical sign score: 0( best) - 18 (worse)

Measure: Mean change in clinical sign score between day 1 and day 7

Time: day 1, day 7 or hospital discharge, whichever is first

Description: Clinical sign score: 0( best) - 18 (worse)

Measure: Mean change in clinical sign score between day 1 and day 15

Time: day 1, day 15 or hospital discharge, whichever is first

Description: Clinical sign score: 0( best) - 18 (worse)

Measure: Time to clinical sign score <6 maintained for 24h

Time: during hospital admission (up to 28 days)

Description: SOFA score: 0 (best) - 24 (worse)

Measure: Mean change of SOFA score (Sequential Organ Failure Assessment) between day 1 and day 7

Time: Day 1, day 7or hospital discharge, whichever is first

Description: SOFA score: 0 (best) - 24 (worse)

Measure: Mean change of SOFA score between day 1 and day 15

Time: day 1, day 15 or hospital discharge, whichever is first

Description: NEWS2 score: 0 (best) - 24 (worse)

Measure: Mean change NEWS2 (National Early Warning) score between day 1 and day 7

Time: day 1, day 7 or hospital discharge, whichever is first

Description: NEWS2 score: 0 (best) - 24 (worse)

Measure: Mean change NEWS2 score between day 1 and day 15

Time: day 1, day 15 or hospital discharge, whichever is first

Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-1

Time: at day 15 or hospital discharge, whichever is first

Description: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-6

Time: at day 15 or hospital discharge, whichever is first

Measure: Incidence of nosocomial bacterial or invasive fungal infection

Time: during hospital admission (up to 28 days)

Description: defined by Hs (Hemophagocytic Syndrome) score

Measure: incidence of secondary haemophagocytic lymphohistiocytosis

Time: during hospital admission (up to 28 days)

Description: defined by Hs score

Measure: Incidence of secondary haemophagocytic lymphohistiocytosisscore in relation to serum IL-1

Time: during hospital admission (up to 28 days)

Description: defined by Hs score

Measure: Incidence of secondary haemophagocytic lymphohistiocytosis in relation to serum IL-6

Time: during hospital admission (up to 28 days)

Measure: Time to first use of high-flow oxygen devices, non-invasive or invasive mechanical ventilation in non-ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Time to first use of salvage systemic steroids in ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Number of ventilator free days

Time: during hospital admission (up to 28 days)

Measure: Duration of mechanical ventilation in ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Duration of ICU stay in patients that enrolled in trial while already on invasive or non-invasive mechanical ventilation

Time: during hospital admission (up to 28 days)

Measure: Time to progression to ARDS in ventilated patients

Time: during hospital admission (up to 28 days)

Measure: Time to progression to ARDS in ventilated patients according to IL-1

Time: during hospital admission (up to 28 days)

Measure: Time to progression to ARDS in ventilated patients according to IL-6

Time: during hospital admission (up to 28 days)

Measure: All-cause mortality rate (excluding group that entered during ventilation)

Time: during hospital admission (up to 28 days)

Measure: Percentage of patients in clinical status on 6-point Ordinal Scale

Time: at 10-20 weeks follow-up

Measure: Incidence of lung function abnormalities

Time: at 10-20 weeks follow-up

Measure: Incidence of lung fibrosis on chest CT scan

Time: at 10-20 weeks follow-up

Measure: All-cause mortality rate

Time: at 10-20 weeks follow-up

4 Efficiency in Management of Organ Dysfunction Associated With Infection by the Novel SARS-CoV-2 Virus (COVID-19) Through a Personalized Immunotherapy Approach: the ESCAPE Clinical Trial

Our aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.

NCT04339712 COVID-19 Virus Diseases Macrophage Activation Syndrome Corona Virus Infection Drug: Anakinra Drug: Tocilizumab
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Macrophage Activation Syndrome Virus Diseases

Primary Outcomes

Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8

Measure: Change of baseline total sequential organ failure assessment (SOFA) score

Time: Visit study day 8

Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8

Measure: Improvement of lung involvement measurements

Time: Visit study day 8

Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8

Measure: Increase of pO2/FiO2 ratio

Time: Visit Study Day 8

Secondary Outcomes

Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators

Time: Screening, Day 8

Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of sequential organ failure assessment (SOFA) score

Time: Day 28

Description: Mortality on day 28

Measure: Rate of Mortality

Time: Day 28

Description: Mortality on day 90

Measure: Rate of Mortality

Time: Day 90

Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Cytokine stimulation

Time: Screening, Day 4

Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4

Measure: Gene expression

Time: Screening, Day 4

Description: Change of serum/plasma proteins between days 0 and 4

Measure: Serum/plasma proteins

Time: Screening, Day 4

Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation

Measure: Classification of the immune function

Time: Screening

5 CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection, Nested In The CORIMUNO-19

The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

NCT04341584 Corona Virus Infection Drug: Anakinra
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

Measure: Survival without needs of ventilator utilization at day 14

Time: 14 days

Description: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5.

Measure: WHO progression scale ≤ 5

Time: 4 days

Description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14

Time: 14 days

Description: Proportion of patients with a decrease of WHO score of at least 1 point at day 4

Measure: Decrease of at least one point in WHO progression scale score

Time: 4 days

Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10.

Measure: WHO progression scale

Time: 7 and 14 days

Description: Overall survival.

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours.

Measure: Respiratory acidosis

Time: 4 days

Description: Evolution of PaO2/FiO2 ratio.

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: Time to oxygen supply independency.

Measure: Time to oxygen supply independency

Time: 14 days

Description: Duration of hospitalization.

Measure: Duration of hospitalization

Time: 90 days

Description: Time to negative viral excretion.

Measure: Time to negative viral excretion

Time: 90 days

Description: Time to ICU discharge.

Measure: Time to ICU discharge

Time: 90 days

Description: Time to hospital discharge.

Measure: Time to hospital discharge

Time: 90 days

6 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

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. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.

NCT04357366 COVID-19 Virus Diseases Co Corona Virus Infection Lower Respiratory Tract Infection Viral Drug: Anakinra Drug: trimethoprim/sulfamethoxazole
MeSH:Infection Communicable Di Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Virus Diseases
HPO:Respiratory tract infection

Primary Outcomes

Description: The primary study endpoint is the ratio of patients who will not develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered non-achieving the primary endpoint.

Measure: The ratio of patients who will not develop serious respiratory failure (SRF)

Time: Visit study day 14

Secondary Outcomes

Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of the rate of patients who will not develop serious respiratory failure (SRF) until day 14 with historical comparators from Hellenic Sepsis Study Group Database

Time: Visit study day 14

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14

Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of SOFA score in enrolled subjects between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14

Time: Visit study day 1, visit study day 14

Description: Change of cytokine stimulation from peripheral blood mononuclear cells of enrolled subjects will be compared between days 1 and 7

Measure: Change of cytokine production between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7

Measure: Change of plasma inflammatory mediators levels between days 1 and 7

Time: Visit study day 1, visit study day 7

7 Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19

This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.

NCT04362111 Cytokine Storm COVID-19 Drug: Anakinra Drug: Normal saline

Primary Outcomes

Description: Supplemental oxygen requirement to maintain oxygen saturation >90% stable or decreased without escalation of respiratory measures (addition of CPAP, initiation of mechanical ventilation)

Measure: No increase in oxygen requirement and no increase in respiratory support measures

Time: 48 hours

Secondary Outcomes

Description: 25% decrease in noted baseline elevations of serum ferritin, LDH, CRP, and d-dimer.

Measure: Improvement in Cytokine Storm markers

Time: 72 hours

Description: Subjects discharged from hospital without the need for mechanical ventilation

Measure: No requirement for mechanical ventilation

Time: Day 5 (120 hours)


Related HPO nodes (Using clinical trials)


HP:0011947: Respiratory tract infection
Genes 633
TIMM8A DNAH9 SIK1 ARID1B NFKBIA GTF2H5 IER3IP1 TNFRSF11A GUSB TBC1D24 BIRC3 IL17RA SPAG1 MSN WDR34 CTSC GAS2L2 NIPBL BTK NFKB1 FCGR3A CRELD1 IGLL1 RNF168 ZBTB24 STAT3 RFX5 TAF1 MKRN3 PLEC CFTR IRAK4 COLQ DNAAF4 TCTN3 MYO9A TGFB1 LEPR SLC18A3 TAP2 LAMA2 PEPD NGLY1 CFAP300 WAS DNAI1 TBCD DNAAF2 SELENON IL2RG IRAK4 ARMC4 SOX4 RSPH1 IFNGR1 GLI3 ALOX12B DNAL1 ZMYND10 UNG NRAS RFXAP IL2RB NKX2-1 RSPH9 PLOD1 SPINK5 SCNN1B GBA GAS8 CFAP298 CLCA4 GNPTAB LEP CLIP2 CCDC65 CD3G FCN3 CYBA SMN1 TRIP4 EP300 USB1 UBB DOCK8 LAMTOR2 TBC1D24 NECTIN1 SAMD9 SCNN1G CCNO CIITA MUC5B HLA-DPB1 DNAAF1 LCK ICOS NPM1 SPAG1 CCDC40 TRAIP CARD11 RSPH4A TBL2 ASAH1 PTPRC ALMS1 RUNX2 DNAAF4 NOTCH3 SH3KBP1 SNORD115-1 DNAI1 BACH2 RAG2 TSC1 TNFRSF13C IDUA IL2RG DNAAF6 GALNS IDUA SLC25A22 FUCA1 B2M SFTPC FLI1 CD3E MGP CD8A ELANE SULT2B1 TCF3 SLC29A3 RELB TPM2 CCDC103 ACTA1 HELLS FCGR2A LAMB2 SLC5A7 SPEF2 AGA SDR9C7 PYROXD1 CLEC7A HERC2 KRAS SMPD1 SOX11 CD247 MESP2 DDR2 GTF2I BLNK KIAA0586 BLNK FOXP1 SMARCA4 EDARADD SGCG MYSM1 ARID1A GNS CD79B MPLKIP LYST NPAP1 NCF1 CYP4F22 SRP54 TPP2 RNU4ATAC TRIP11 NGLY1 LRBA DNMT3B P4HTM SELENON STX1A TRPS1 COL13A1 TNFRSF13B DNAAF5 VPS13A CD81 INPPL1 CARMIL2 TAP1 NOTCH2 MESP2 GATA2 SNX10 CSF2RB SDCCAG8 JAK3 TBCE DOCK8 SHROOM4 RTEL1 OSTM1 CCDC151 LETM1 SMPD1 IL21 DNAJB13 JAK3 RNF125 INSR STK36 SCN10A IL7R MYH3 POLA1 CD19 CR2 ARID1B CD3D RSPH3 TAPBP CYBB DRC1 VAMP1 ADNP DCLRE1C PTPN22 NDN SGSH ARSB LRRC56 LRRC6 SP110 CCDC40 SLC25A1 ASAH1 PCGF2 BTK CCBE1 COL6A1 GATA6 PGM3 COG4 PSAP SLC46A1 SCN9A IKBKB CFB GAS2L2 TGFB1 PEPD SMARCC2 RNU4ATAC MYL2 SCN11A COL6A2 POLR3A GTF2E2 TSC2 WRAP53 ITGA3 CFI SCNN1B BTK CCDC22 DNAI2 CFTR ZAP70 DCTN4 CD79B RYR1 ADAMTS3 CD81 PLG SYT2 USP9X DKC1 KIF1A PRPS1 ELANE AFF4 ALB NME8 TNFRSF13C MAP3K20 TNFSF12 TIRAP STAT3 CCDC114 ADA SMARCE1 DSG1 PIK3R1 RPGR CREBBP HACD1 PRTN3 NFE2L2 DPM2 FLNA RMRP DNAH11 ERF EPM2A HYDIN G6PC3 ATM GAS8 SNORD116-1 DNAH11 NFKB2 EPG5 BCL10 DPF2 BAZ1B ERCC2 AK2 EHMT1 MS4A1 DNAAF3 CCDC151 LIG4 NFKB2 FBLN5 ZMYND10 ATP6V0A2 IL17RA TARS1 NXN COL6A3 TCIRG1 RFC2 WASHC5 WIPF1 GATA4 NOP10 RFXANK RSPH4A HLA-B SLC52A3 NME8 NHP2 CXCR4 GSN PCNT TNFRSF13B LEP IL17RC AGRN CORO1A CCDC65 RPGR NADK2 CD55 GTF2IRD1 IL17F ALG12 COL11A2 NHLRC1 ABCA12 LTBP3 SCNN1B ABCA12 NSD2 TECPR2 MANBA PARN GFI1 EPG5 NBN FLNA RNF113A CCDC39 PMM2 SCNN1A ICOS RFXANK TNFSF12 PWRN1 CARD11 SFTPC MGP USB1 OFD1 JAGN1 LRRC6 TYK2 IL21R FMO3 CFTR AGA PLP1 STAT1 NR2F2 CYBC1 SLC35A1 HLA-DPA1 RIPK1 DNAAF1 ORC6 RAG2 HPS6 CACNA1C GMNN IDUA RYR1 CFAP298 KIAA0556 TNFRSF13B AICDA KDM6A CLCN7 PANK2 SAMD9L RANBP2 ROR2 ELN CIITA TPM3 RSPH3 ADA DNAAF2 KMT2D ZNF341 GBA TNFRSF1A IL7R LEPR NAGLU RAG2 COG4 SCNN1A IGHM DLL3 TRAF3IP2 CSF2RA LAMTOR2 BLM NSMCE3 UMPS PGM3 RFX5 GRHL3 EGFR ELP1 PNP LIPN DNAH5 HGSNAT SETBP1 ECM1 TTC25 CR2 ADA MASP2 SFTPA2 AP3D1 MBTPS2 RAC1 TTC25 KAT6B ZAP70 IFIH1 ALPL IGHM SCNN1G DNAAF5 RAG2 NBN FAT4 SNRPN CD19 TGM1 ACADVL TNFSF11 CYBB PTPN22 PEX13 TK2 CACNA1B GAA PRKDC ARMC4 ALOXE3 CR2 CYBA RAG1 NCF1 SNAP25 CDCA7 IPW CXCR4 TERC RAG1 CD19 CD3E CD79A DNAH5 TFRC MCM4 FOXP3 IRF8 CFAP221 CTC1 LYST DNAI2 KCNJ6 EXOSC9 CD3D CRKL RYR1 CCDC114 PLG DCLRE1C SLC25A24 DCLRE1C LRRC8A ICOS TGFB1 CTLA4 XIAP IL7R IKBKG VPS33A FOXJ1 NELFA IL2RG CASP8 RAG1 CHAT IGLL1 CFAP410 CCNO ALMS1 NCF2 UNC119 GLB1 CHRM3 RSPH1 TNFRSF13C ERCC3 LIMK1 CTLA4 CD79A RAG1 SLC26A2 STAT1 DNAH1 RSPH9 CFTR NCF2 WAS MECP2 CCDC103 IL2RA SLC12A6 ACTA1 IKBKB ATM DNAAF3 LRRC56 RAB3GAP2 PIGN MAGEL2 IKZF1 PRKCD ACP5 CHAMP1 SLC35C1 MKRN3-AS1 HYDIN SH2D1A MTHFD1 SMARCB1 NCF4 RAG1 XIAP MAPK1 PIK3R1 TERT PWAR1 CHD7 IGH OCRL MS4A1 DNAAF6 PIK3R1 SMARCD2 CCDC39 TBX6 UBE2A STING1 NKX2-1 ELP1 OFD1 COL13A1 ARID2 ZBTB24 TINF2 MYO5A WDR19 GNPTAB COL11A2 NFIX RAG2 SCNN1A RFXAP PLCG2 USP9X NFKB1 NIPAL4 NCF4 ZNHIT3 MALT1 SCNN1G IL2RG BCR POLE TCIRG1 INPPL1 TBC1D23 GBA DNAJB13 GUSB PIK3CD ITGA7 CSPP1 SMN1 TERT DNMT3B NFKB2 MCIDAS DCLRE1C
Protein Mutations 1
H275Y
SNP 0