Covid 19 Research using Clinical Trials (Home Page)
EmapalumabWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
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There is one clinical trial.
Clinical Trials
1 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 15Secondary Outcomes
Description: Measured in days
Measure: Time to mechanical ventilation Time: Date of randomization to date of mechanical ventilationDescription: Measured in total score
Measure: Change from baseline in Modified Early Warning system score Time: Baseline, Day 15Description: 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 15Description: Measured in percent (%)
Measure: Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) Time: Baseline, Day 15Description: Measured in local units
Measure: Change of pH in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of oxygen tension (pO2) in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of potassium in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of sodium in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of chloride in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of lactic acid in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of hemoglobin in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in l/min
Measure: Change from baseline in oxygen supplementation Time: Baseline, Days 4, 7, 10, 13 and 15Description: 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 15Description: Measured in local units
Measure: Change from baseline in Ferritin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in lactate dehydrogenase (LDH) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in D-dimers Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in White Blood Cells with differential counts Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Red Blood Counts Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Hemoglobin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Platelet count Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Fibrinogen Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Complement factors C3/C4 Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Prothrombin time Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Cardiac troponin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in aspartate aminotransferase (AST) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in alanine aminotransferase (ALT) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in total bilirubin levels Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in C-Reactive Protein Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Creatinine Time: Baseline, Days 4, 7, 10, 13 and 15Description: Confirmation of death
Measure: Overall survival Time: Weeks 6 and 10Description: Measured in days
Measure: Time to hospital discharge Time: Weeks 6 and 10