The primary objective of this study is to demonstrate (at the time of admission) biomarkers
of interest (Human Plasma BAK125 panel + interferon panel) for dexamethasone responders
versus non-responders in SARS-CoV-2 hypoxemic pneumonia.
The secondary objectives are to describe and compare between groups:
- The number of days without mechanical ventilation
- The need for mechanical ventilation
- 28-day mortality
- Progression towards acute respiratory distress syndrome (ARDS)
- Change in the qSOFA score
- Length of hospitalization
- The change in the extent of lesions on thoracic computed tomography scan between
inclusion and D7 (or the day of discharge from hospital if Description: Treatment failure is defined as the need to transfer the patient to intensive care for mechanical ventilation. Description: PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc Description: PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc Description: Measured at least twice per day throughout the initial hospitalization period. Description: Measured at least twice per day throughout the initial hospitalization period. Description: Measured at least twice per day throughout the initial hospitalization period. Description: Measured at least twice per day throughout the initial hospitalization period. Description: Measured at least twice per day throughout the initial hospitalization period. Description: Measured at least twice per day throughout the initial hospitalization period. Description: Measured at least twice per day throughout the initial hospitalization period. Description: Capillary glycemia will be measured at least twice per day throughout the initial hospitalization period. Description: The Quick Sequential Organ Failure Assessment (qSOFA) score will be assessed at least twice per day throughout the initial hospitalization period.
The quick Sepsis-related organ failure assessment (qSOFA) score ranges from 0 to 3 points, with '3' indicating the worst health state. It uses three criteria, assigning one point for low blood pressure (systolic blood pressure ≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation. Description: CD4 refers to cluster of differentiation 4. Description: CD4 refers to cluster of differentiation 4. Description: CD4 refers to cluster of differentiation 4. Description: CD4 refers to cluster of differentiation 4. Description: CD8 refers to cluster of differentiation 8. Description: CD8 refers to cluster of differentiation 8. Description: CD8 refers to cluster of differentiation 8. Description: CD8 refers to cluster of differentiation 8. Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment Cohort There is one SNP The secondary objectives are to describe and compare between groups:
- The number of days without mechanical ventilation
- The need for mechanical ventilation
- 28-day mortality
- Progression towards acute respiratory distress syndrome (ARDS)
- Change in the qSOFA score
- Length of hospitalization
- The change in the extent of lesions on thoracic computed tomography scan between
inclusion and D7 (or the day of discharge from hospital if Club cell secrectory protein polymorphism A38G. --- A38G --- NCT04619693 Pneumonia, Viral SARS-Cov-2
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia
Primary Outcomes
Secondary Outcomes
Measure: Circulating blood interferon level Time: Baseline (day 0)
Measure: Circulating blood interferon level Time: Day 7
Measure: Hemoglobin Time: Baseline (day 0)
Measure: Hemoglobin Time: Day 2
Measure: Hemoglobin Time: Day 4
Measure: Hemoglobin Time: Day 7 (or day of discharge if before day 7)
Measure: Platelet count Time: Baseline (day 0)
Measure: Platelet count Time: Day 2
Measure: Platelet count Time: Day 4
Measure: Platelet count Time: Day 7 (or day of discharge if before day 7)
Measure: White blood cell count Time: Baseline (day 0)
Measure: White blood cell count Time: Day 2
Measure: White blood cell count Time: Day 4
Measure: White blood cell count Time: Day 7 (or day of discharge if before day 7)
Measure: Neutrophil percentage Time: Baseline (day 0)
Measure: Neutrophil percentage Time: Day 2
Measure: Neutrophil percentage Time: Day 4
Measure: Neutrophil percentage Time: Day 7 (or day of discharge if before day 7)
Measure: Eosinophil percentage Time: Baseline (day 0)
Measure: Eosinophil percentage Time: Day 2
Measure: Eosinophil percentage Time: Day 4
Measure: Eosinophil percentage Time: Day 7 (or day of discharge if before day 7)
Measure: Basophil percentage Time: Baseline (day 0)
Measure: Basophil percentage Time: Day 2
Measure: Basophil percentage Time: Day 4
Measure: Basophil percentage Time: Day 7 (or day of discharge if before day 7)
Measure: Lymphocyte percentage Time: Baseline (day 0)
Measure: Lymphocyte percentage Time: Day 2
Measure: Lymphocyte percentage Time: Day 4
Measure: Lymphocyte percentage Time: Day 7 (or day of discharge if before day 7)
Measure: Monocyte percentage Time: Baseline (day 0)
Measure: Monocyte percentage Time: Day 2
Measure: Monocyte percentage Time: Day 4
Measure: Monocyte percentage Time: Day 7 (or day of discharge if before day 7)
Measure: Prothrombin rate (%) Time: Baseline (day 0)
Measure: Prothrombin rate (%) Time: Day 2
Measure: Prothrombin rate (%) Time: Day 4
Measure: Prothrombin rate (%) Time: Day 7 (or day of discharge if before day 7)
Measure: Activated partial thromboplastin time ratio Time: Baseline (Day 0)
Measure: Activated partial thromboplastin time ratio Time: Day 2
Measure: Activated partial thromboplastin time ratio Time: Day 4
Measure: Activated partial thromboplastin time ratio Time: Day 7 (or day of discharge if before day 7)
Measure: Fibrinogen (g/L) Time: Baseline (Day 0)
Measure: Fibrinogen (g/L) Time: Day 2
Measure: Fibrinogen (g/L) Time: Day 4
Measure: Fibrinogen (g/L) Time: Day 7 (or day of discharge if before day 7)
Measure: D-Dimers (μg/mL) Time: Baseline (Day 0)
Measure: D-Dimers (μg/mL) Time: Day 2
Measure: D-Dimers (μg/mL) Time: Day 4
Measure: D-Dimers (μg/mL) Time: Day 7 (or day of discharge if before day 7)
Measure: Aspartate aminotransferase (ASAT; UI/L) Time: Baseline (Day 0)
Measure: Aspartate aminotransferase (ASAT; UI/L) Time: Day 2
Measure: Aspartate aminotransferase (ASAT; UI/L) Time: Day 4
Measure: Aspartate aminotransferase (ASAT; UI/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Alanine aminotransferase (ALAT; UI/L) Time: Baseline (Day 0)
Measure: Alanine aminotransferase (ALAT; UI/L) Time: Day 2
Measure: Alanine aminotransferase (ALAT; UI/L) Time: Day 4
Measure: Alanine aminotransferase (ALAT; UI/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Glucose (mmol/L) Time: Baseline (Day 0)
Measure: Glucose (mmol/L) Time: Day 2
Measure: Glucose (mmol/L) Time: Day 4
Measure: Glucose (mmol/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Glycated haemoglobin (HbA1c; %) Time: Baseline (Day 0)
Measure: Glycated haemoglobin (HbA1c; %) Time: Day 2
Measure: Glycated haemoglobin (HbA1c; %) Time: Day 4
Measure: Glycated haemoglobin (HbA1c; %) Time: Day 7 (or day of discharge if before day 7)
Measure: Urea (mmol/L) Time: Baseline (Day 0)
Measure: Urea (mmol/L) Time: Day 2
Measure: Urea (mmol/L) Time: Day 4
Measure: Urea (mmol/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Creatinine (µmol/L) Time: Baseline (Day 0)
Measure: Creatinine (µmol/L) Time: Day 2
Measure: Creatinine (µmol/L) Time: Day 4
Measure: Creatinine (µmol/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2) Time: Baseline (Day 0)
Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2) Time: Day 2
Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2) Time: Day 4
Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2) Time: Day 7 (or day of discharge if before day 7)
Measure: Albumin (g/L) Time: Baseline (Day 0)
Measure: Albumin (g/L) Time: Day 2
Measure: Albumin (g/L) Time: Day 4
Measure: Albumin (g/L) Time: Day 7 (or day of discharge if before day 7)
Measure: C reactive protein (CRP, mg/L) Time: Baseline (Day 0)
Measure: C reactive protein (CRP, mg/L) Time: Day 2
Measure: C reactive protein (CRP, mg/L) Time: Day 4
Measure: C reactive protein (CRP, mg/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Lactate dehydrogenase (LDH, UI/L) Time: Baseline (Day 0)
Measure: Lactate dehydrogenase (LDH, UI/L) Time: Day 2
Measure: Lactate dehydrogenase (LDH, UI/L) Time: Day 4
Measure: Lactate dehydrogenase (LDH, UI/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Hypersensitive troponin T (µg/L) Time: Baseline (Day 0)
Measure: Hypersensitive troponin T (µg/L) Time: Day 2
Measure: Hypersensitive troponin T (µg/L) Time: Day 4
Measure: Hypersensitive troponin T (µg/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Ferritin (µg/L) Time: Baseline (Day 0)
Measure: Ferritin (µg/L) Time: Day 2
Measure: Ferritin (µg/L) Time: Day 4
Measure: Ferritin (µg/L) Time: Day 7 (or day of discharge if before day 7)
Measure: Natural killer cell count Time: Baseline (Day 0)
Measure: Natural killer cell count Time: Day 2
Measure: Natural killer cell count Time: Day 4
Measure: Natural killer cell count Time: Day 7 (or day of discharge if before day 7)
Measure: Activated T cell percentage Time: Baseline (Day 0)
Measure: Activated T cell percentage Time: Day 2
Measure: Activated T cell percentage Time: Day 4
Measure: Activated T cell percentage Time: Day 7 (or day of discharge if before day 7)
Measure: Change in SARS-CoV-2 real-time polymerase chain reaction cycle threshold Time: Baseline to day 7 (or day of discharge if before day 7)
Measure: Change in SARS-CoV-2 IgG serology (% of control signal = PCS) Time: Baseline to day 7 (or day of discharge if before day 7)
Measure: Change in SARS-CoV-2 IgM serology (% of control signal = PCS) Time: Baseline to day 7 (or day of discharge if before day 7)
Measure: Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 real time polymerase chain reaction Time: Day 7 (or day of discharge if before day 7)
Measure: Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 IgG serology Time: Day 7 (or day of discharge if before day 7)
Measure: Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 IgM serology Time: Day 7 (or day of discharge if before day 7)
Measure: Requirement for low flow oxygen therapy during the initial hospitalisation: yes/no Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Requirement for high flow oxygen therapy during the initial hospitalisation: yes/no Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Requirement for non-invasive ventilation during the initial hospitalisation: yes/no Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Requirement for invasive ventilation during the initial hospitalisation: yes/no Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Requirement for dialysis during the initial hospitalisation: yes/no Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Requirement for extracorporeal membrane oxygenation during the initial hospitalisation: yes/no Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Classification of acute respiratory distress syndrome (ARDS) according to the Berlin criteria during initial hospitalization: absent, mild, moderate or severe Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Length of stay (hours) in intensive care Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Length of stay (hours) in hospital Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Days alive and without low flow oxygen therapy Time: Day 28
Measure: Days alive and without high flow oxygen therapy Time: Day 28
Measure: Days alive and without any oxygen therapy Time: Day 28
Measure: Days alive and without non-invasive ventilation Time: Day 28
Measure: Days alive and without invasive ventilation Time: Day 28
Measure: Days alive and without extracorporeal membrane oxygenation Time: Day 28
Measure: Days alive and without intensive care Time: Day 28
Measure: Days alive and without hospitalisation Time: Day 28
Measure: Mortality Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Mortality Time: Day 28
Measure: Club cell secrectory protein polymorphism A38G Time: Between day 0 and day 28Other Outcomes
Measure: Presence/absence of incident hyperglycemia during hospitalization Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Presence/absence of secondary infection during hospitalization Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Presence/absence of cardiovascular event (ischemic, stroke, other) during hospitalization Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Presence/absence of digestive hemorrhage during hospitalization Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Presence/absence of neuro-psychiatric event (acute delirium, depressive syndrome, decompensation of an underlying psychiatric pathology) during hospitalization Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Adverse events Time: Day of hospital discharge (expected maximum of 28 days)
Measure: Adverse events Time: Day 28Time Perspective: Prospective
SNPs
1 A38G