CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


AnakinraWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (35)


Name (Synonyms) Correlation
drug1425 Macrolide administered for up to 14 days Wiki 0.38
drug837 Emapalumab Wiki 0.38
drug2338 Standard therapy Wiki 0.38
drug1227 Interferon-β1a Wiki 0.38
drug1424 Macrolide administered for 3-5 days Wiki 0.38
drug949 Fixed-duration Hydrocortisone Wiki 0.38
drug1932 Protocolised mechanical ventilation strategy Wiki 0.38
drug2254 Shock-dependent hydrocortisone Wiki 0.38
drug1092 Hydroxychloroquine + lopinavir/ritonavir Wiki 0.38
drug1820 Piperacillin-tazobactam Wiki 0.38
drug156 Amoxicillin-clavulanate Wiki 0.38
drug803 ECCO2R Wiki 0.38
drug3035 trimethoprim/sulfamethoxazole Wiki 0.38
drug950 Fixed-duration higher dose Hydrocortisone Wiki 0.38
drug532 Ceftriaxone Wiki 0.38
drug1079 Human milk donors Wiki 0.38
drug946 Five-days oseltamivir Wiki 0.38
drug1523 Moxifloxacin or Levofloxacin Wiki 0.38
drug1771 Patient Navigation Program Wiki 0.38
drug998 Gimsilumab Wiki 0.38
drug531 Ceftaroline Wiki 0.38
drug2472 Ten-days oseltamivir Wiki 0.38
drug2499 Therapeutic anticoagulation Wiki 0.27
drug2263 Simvastatin Wiki 0.27
drug1023 HCQ Wiki 0.27
drug2256 Siltuximab Wiki 0.27
drug2527 Tocilizumab Wiki 0.21
drug2612 Usual Care Wiki 0.17
drug2197 Sarilumab Wiki 0.17
drug1645 Normal saline Wiki 0.17
drug1372 Lopinavir/ritonavir Wiki 0.12
drug2662 Vitamin C Wiki 0.11
drug658 Convalescent plasma Wiki 0.09
drug1086 Hydroxychloroquine Wiki 0.04
drug1822 Placebo Wiki 0.02

Correlated MeSH Terms (12)


Name (Synonyms) Correlation
D055501 Macrophage Activation Syndrome NIH 0.38
D014777 Virus Diseases NIH 0.09
D007239 Infection NIH 0.09
D055370 Lung Injury NIH 0.08
D012141 Respiratory Tract Infections NIH 0.08
D055371 Acute Lung Injury NIH 0.08
D012127 Respiratory Distress Syndrome, Newborn NIH 0.07
D012128 Respiratory Distress Syndrome, Adult NIH 0.07
D003141 Communicable Diseases NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D018352 Coronavirus Infections NIH 0.05
D011014 Pneumonia NIH 0.02

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.08
HP:0002090 Pneumonia HPO 0.02

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 of 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 Drug: Vitamin C Drug: Therapeutic anticoagulation Drug: Simvastatin Drug: Convalescent plasma Other: Protocolised mechanical ventilation strategy
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 not receiving organ support in 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: 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: 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, according to the adapted Berlin criteria

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

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 Dis Virus Diseases Corona Virus Infection Lower Respiratory Tract Infection Viral Drug: Anakinra Drug: trimethoprim/sulfamethoxazole
MeSH:Infection 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 664
CCDC39 KMT2D RSPH1 DOCK8 NKX2-1 CCNO SPAG1 LIMK1 MPLKIP RAG1 DSG1 BIRC3 ELP1 TSC2 IL17F BLNK BACH2 SGSH IKBKB CD79A AFF4 ARID1B TNFRSF13C CD19 DNAH1 MYO5A AICDA NOTCH3 ELN LAMTOR2 NADK2 CTLA4 DPM2 PWAR1 GATA6 SFTPC FOXN1 MESP2 ELANE CD81 PNP MED25 ZAP70 RAG2 WRAP53 DNAAF1 STAT3 ATM LTBP3 CLCA4 DNAH9 BTK RSPH3 TERT TYK2 LRBA RSPH4A SOX11 RYR1 TNNT2 SMARCD2 GAS8 SLC5A7 KIF1A ROR2 NCF4 COLQ TNFRSF13B HLA-B CCDC65 COL11A2 ORC6 DCLRE1C CTLA4 CACNA1C GBA RNF113A ICOS SETBP1 CYBC1 MGP VPS33A COL13A1 MYSM1 DNAAF4 FLI1 MECP2 MAN2B1 HLA-DQA1 SCNN1A GLB1 IL21R CSF2RB SELENON INPPL1 CD3G ACADVL COL6A3 NSMCE3 AGA CCDC65 HGSNAT AP3D1 NFIX EXOSC9 RAG2 KIAA0586 FCGR2A ABCA12 NFKB2 TFRC NDN MAPK1 LAMA2 NCF4 ARSB LYST RAG1 TPP2 TGFB1 INPPL1 RAG2 TNFSF11 XIAP UNG SCNN1A DNAAF6 SCN10A IL2RG CCDC103 CLCN7 IGHM GNPTAB DNAAF4 CXCR4 PLEC HLA-DPB1 OCRL RFXAP SCN11A CFB TNNI3 TINF2 DCLRE1C MAGEL2 TAF1 SCNN1B CARD11 USB1 GTF2IRD1 CCDC103 SNORD115-1 IL2RG HLA-DQB1 TBC1D23 DLL3 RFXANK MYO9A SCNN1G CD79A ICOS RFC2 TAP1 CD3D FOXJ1 AGRN PIK3R1 WIPF1 RSPH4A IL2RG ACTA1 SRP54 RPGR SNAP25 TSC1 CORO1A IRF8 NCF2 GAS8 ZNHIT3 FOXP1 EP300 JAGN1 ZBTB24 TGFB1 TNFRSF13B CD3E DNAL1 EXTL3 NCF1 SNRPN B2M CLIP2 SCNN1G SFTPC LRRC56 WAS RMRP FUCA1 RSPH9 PEX13 GATA4 CFI ERCC3 FOXP1 ITGA3 PCGF2 TNFRSF13C ATP6V0A2 DNMT3B LEP BCR ZBTB24 NELFA RNF125 NECTIN1 EPM2A TGM1 CCDC40 JAK3 NEK10 MYPN RAC1 CREBBP DNAI2 PLG DDR2 UGP2 NME8 COL6A1 SLC25A1 ECM1 CD3E NFKBIA IGLL1 CHRM3 PRTN3 COG6 CD8A STX1A DNAI1 CYBB IDUA GSN EPG5 TCIRG1 DNAJB13 EDARADD TERT CR2 SOX4 NSD2 GAA TARS1 LEPR ELP1 ALMS1 IL2RB SULT2B1 RAG2 SLC25A24 SMPD1 WDR19 CHAMP1 DNAJB13 FOXP3 RNU4ATAC PLP1 ARID1A CFAP410 BTK TCTN3 RFXANK MYH3 FCN3 SMARCE1 ALPL SLC18A3 IL17RA NR2F2 NKX2-1 SCNN1G CCBE1 SLC52A3 PWRN1 DCLRE1C RYR1 AGA CIITA CR2 LRRC6 PIGN CFAP298 DNAAF5 CCNO BLM CFTR NCF1 CR2 IL2RA LCK UMPS USP9X CD3D ARID2 RUNX2 SLC35C1 TIMM8A NGLY1 NFKB2 CCDC114 TPM3 SCNN1B ADA LRRC56 PEPD IPW KATNIP LYST GRHL3 CCDC151 NBN SYT2 SPAG1 PRKCD LAMB2 CTC1 PMM2 DNAAF3 FLNC DNAAF1 POLR3A LIPN STAT1 TECPR2 SCNN1B RAG1 SDR9C7 ASAH1 DNAAF6 CRELD1 MYSM1 OSTM1 GBA CYBA RNU4ATAC COL13A1 VAMP1 MGP SMARCC2 MCIDAS G6PC3 IL17RC PSAP KAT6B PIK3R1 CD81 SLC1A4 NOP10 NGLY1 MANBA SHROOM4 ALB SMARCD1 SCNN1A CD19 ALMS1 GUSB TTC25 SMN1 RIPK1 UNC119 IGHM CD79B CFAP221 SAMD9 CYP4F22 GTF2H5 GLI3 IGLL1 SLC29A3 RPGR SCNN1B STK36 PLOD1 DNAAF5 GMNN RAG1 GNS COL11A2 OFD1 TNFRSF11A MALT1 NFE2L2 CD19 DCTN4 COG4 SCNN1A CD40LG NME8 SELENON ADNP CFTR NPAP1 CFTR DOCK8 CFAP298 SMPD1 RAG1 P4HTM MAN2B1 SLC26A2 CFAP300 RAB3GAP2 ALG12 JAK3 GTF2E2 IL21 BCL10 NRAS PRKDC TNFRSF13C SH3KBP1 ZNF341 NXN RSPH9 RFXAP SPEF2 MSN LIG4 MCM4 TBCE GALNS SLC12A6 NIPBL STAT3 ZMYND10 IL7R NAGLU HELLS CTSC NIPAL4 RASGRP1 SMARCB1 SP110 LETM1 RSPH1 CCDC39 ARMC4 LAMTOR2 TNFRSF1A IKZF1 IKBKB DNAI2 MBTPS2 FBLN5 ACP5 PTPRC NFKB2 ZAP70 TPM2 TCIRG1 NEK10 ARMC4 MS4A1 MTHFD1 CARMIL2 UBE2A EGFR RYR1 ADA DNAI1 PLCG2 PTPN22 DNMT3B BAZ1B TAPBP RTEL1 ABCA12 SNX10 CSF2RA MESP2 SMARCA4 AK2 DNAH11 KCNJ6 HACD1 DCLRE1C SAMD9L PNP ITGA7 ALOXE3 HLA-DPA1 HERC2 SLC46A1 LRRC8A IER3IP1 TSC2 TGFB1 TRAF3IP2 HPS6 ADA ICOS FLNA TRIP4 FMO3 DPF2 GFI1 ARID1B IRAK4 MKRN3-AS1 VPS33A DNAAF2 NOTCH2 SFTPA2 PCNT CRLF1 ELANE DNAH5 NFKB1 PANK2 GBA GAS2L2 GTF2I CD247 STAT1 RAG2 CCDC151 WAS EPG5 SLC25A22 DYNC2I2 XIAP SLC35A1 GNPTAB TK2 MS4A1 IFNGR1 LEPR CRKL CIITA NPM1 ZMYND10 COL6A2 ATM RNF168 GAS2L2 CDCA7 PRPS1 EHMT1 ERF NHLRC1 TBX6 MUC5B VPS13A RFX5 ASAH1 DNAH5 HYDIN FCGR3A RELB ADAMTS3 SCN9A TTC12 SH2D1A PTPN22 LEP CYBA PGM3 IL17RA MKRN3 NOS1 AFF4 ERCC2 SDCCAG8 IFIH1 CD79B TBC1D24 CHD7 GATA2 POLE LRRC6 TERC TNFRSF13B TAP2 CFTR OFD1 WASHC5 RANBP2 IL7R MYL2 TRAIP CCDC22 IGH CCDC40 IL2RG SNORD116-1 ALOX12B NFKB1 STING1 NCF2 TRPS1 SGCG PARN CHAT TSC1 TBL2 CTCF ACTA1 CACNA1B UBB PIK3CD PEPD DNAAF3 TTC25 CARD11 DNAAF2 CXCR4 MASP2 IL6ST TBC1D24 DRC1 TBCD TCF3 CYBB PIK3R1 SMN1 RSPH3 COG4 TNFSF12 CSPP1 KIF20A USP9X NHP2 HYDIN NBN PYROXD1 CASP8 IL7R SCNN1G CCDC114 TNFSF12 BTK SPINK5 BLNK CD55 IDUA USB1 SIK1 FLNA CLEC7A MAP3K20 KPTN RFX5 FAT4 DKC1 KDM6A IDUA POLA1 TRIP11 PGM3 GUSB DNAH11 KRAS
Protein Mutations 1
H275Y
SNP 0