Primary Outcomes

Description: Treatment failure is defined as the need to transfer the patient to intensive care for mechanical ventilation.

Measure: Treatment failure (yes/no)

Time: Hospital discharge (expected maximum of 28 days)

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Secondary Outcomes

Description: PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc

Measure: Human Plasma BAK-125 proteomics profile

Time: Baseline (day 0)

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Description: PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc

Measure: Human Plasma BAK-125 proteomics profile

Time: Day 7

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Measure: Circulating blood interferon level

Time: Baseline (day 0)

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Measure: Circulating blood interferon level

Time: Day 7

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Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of SpO2

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of FiO2

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of temperature (°C)

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of respiratory rate (cycles per minute)

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of pulse (bpm)

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of systolic blood pressure (mmHg)

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Description: Measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of diastolic blood pressure (mmHg)

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Description: Capillary glycemia will be measured at least twice per day throughout the initial hospitalization period.

Measure: A vector of repeated measures of capillary glycemia (g/L)

Time: Throughout initial hospitalization (expected maximum of 28 days)

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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.

Measure: A vector of repeated measures of the qSOFA score

Time: Throughout initial hospitalization (expected maximum of 28 days)

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Measure: Hemoglobin

Time: Baseline (day 0)

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Measure: Hemoglobin

Time: Day 2

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Measure: Hemoglobin

Time: Day 4

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Measure: Hemoglobin

Time: Day 7 (or day of discharge if before day 7)

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Measure: Platelet count

Time: Baseline (day 0)

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Measure: Platelet count

Time: Day 2

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Measure: Platelet count

Time: Day 4

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Measure: Platelet count

Time: Day 7 (or day of discharge if before day 7)

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Measure: White blood cell count

Time: Baseline (day 0)

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Measure: White blood cell count

Time: Day 2

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Measure: White blood cell count

Time: Day 4

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Measure: White blood cell count

Time: Day 7 (or day of discharge if before day 7)

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Measure: Neutrophil percentage

Time: Baseline (day 0)

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Measure: Neutrophil percentage

Time: Day 2

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Measure: Neutrophil percentage

Time: Day 4

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Measure: Neutrophil percentage

Time: Day 7 (or day of discharge if before day 7)

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Measure: Eosinophil percentage

Time: Baseline (day 0)

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Measure: Eosinophil percentage

Time: Day 2

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Measure: Eosinophil percentage

Time: Day 4

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Measure: Eosinophil percentage

Time: Day 7 (or day of discharge if before day 7)

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Measure: Basophil percentage

Time: Baseline (day 0)

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Measure: Basophil percentage

Time: Day 2

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Measure: Basophil percentage

Time: Day 4

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Measure: Basophil percentage

Time: Day 7 (or day of discharge if before day 7)

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Measure: Lymphocyte percentage

Time: Baseline (day 0)

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Measure: Lymphocyte percentage

Time: Day 2

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Measure: Lymphocyte percentage

Time: Day 4

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Measure: Lymphocyte percentage

Time: Day 7 (or day of discharge if before day 7)

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Measure: Monocyte percentage

Time: Baseline (day 0)

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Measure: Monocyte percentage

Time: Day 2

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Measure: Monocyte percentage

Time: Day 4

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Measure: Monocyte percentage

Time: Day 7 (or day of discharge if before day 7)

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Measure: Prothrombin rate (%)

Time: Baseline (day 0)

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Measure: Prothrombin rate (%)

Time: Day 2

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Measure: Prothrombin rate (%)

Time: Day 4

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Measure: Prothrombin rate (%)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Activated partial thromboplastin time ratio

Time: Baseline (Day 0)

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Measure: Activated partial thromboplastin time ratio

Time: Day 2

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Measure: Activated partial thromboplastin time ratio

Time: Day 4

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Measure: Activated partial thromboplastin time ratio

Time: Day 7 (or day of discharge if before day 7)

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Measure: Fibrinogen (g/L)

Time: Baseline (Day 0)

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Measure: Fibrinogen (g/L)

Time: Day 2

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Measure: Fibrinogen (g/L)

Time: Day 4

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Measure: Fibrinogen (g/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: D-Dimers (μg/mL)

Time: Baseline (Day 0)

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Measure: D-Dimers (μg/mL)

Time: Day 2

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Measure: D-Dimers (μg/mL)

Time: Day 4

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Measure: D-Dimers (μg/mL)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Baseline (Day 0)

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Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Day 2

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Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Day 4

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Measure: Aspartate aminotransferase (ASAT; UI/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Baseline (Day 0)

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Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Day 2

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Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Day 4

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Measure: Alanine aminotransferase (ALAT; UI/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Glucose (mmol/L)

Time: Baseline (Day 0)

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Measure: Glucose (mmol/L)

Time: Day 2

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Measure: Glucose (mmol/L)

Time: Day 4

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Measure: Glucose (mmol/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Glycated haemoglobin (HbA1c; %)

Time: Baseline (Day 0)

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Measure: Glycated haemoglobin (HbA1c; %)

Time: Day 2

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Measure: Glycated haemoglobin (HbA1c; %)

Time: Day 4

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Measure: Glycated haemoglobin (HbA1c; %)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Urea (mmol/L)

Time: Baseline (Day 0)

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Measure: Urea (mmol/L)

Time: Day 2

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Measure: Urea (mmol/L)

Time: Day 4

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Measure: Urea (mmol/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Creatinine (µmol/L)

Time: Baseline (Day 0)

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Measure: Creatinine (µmol/L)

Time: Day 2

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Measure: Creatinine (µmol/L)

Time: Day 4

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Measure: Creatinine (µmol/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Baseline (Day 0)

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Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Day 2

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Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Day 4

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Measure: Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Albumin (g/L)

Time: Baseline (Day 0)

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Measure: Albumin (g/L)

Time: Day 2

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Measure: Albumin (g/L)

Time: Day 4

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Measure: Albumin (g/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: C reactive protein (CRP, mg/L)

Time: Baseline (Day 0)

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Measure: C reactive protein (CRP, mg/L)

Time: Day 2

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Measure: C reactive protein (CRP, mg/L)

Time: Day 4

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Measure: C reactive protein (CRP, mg/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Baseline (Day 0)

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Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Day 2

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Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Day 4

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Measure: Lactate dehydrogenase (LDH, UI/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Hypersensitive troponin T (µg/L)

Time: Baseline (Day 0)

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Measure: Hypersensitive troponin T (µg/L)

Time: Day 2

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Measure: Hypersensitive troponin T (µg/L)

Time: Day 4

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Measure: Hypersensitive troponin T (µg/L)

Time: Day 7 (or day of discharge if before day 7)

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Measure: Ferritin (µg/L)

Time: Baseline (Day 0)

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Measure: Ferritin (µg/L)

Time: Day 2

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Measure: Ferritin (µg/L)

Time: Day 4

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Measure: Ferritin (µg/L)

Time: Day 7 (or day of discharge if before day 7)

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Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Baseline (Day 0)

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Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Day 2

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Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Day 4

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Description: CD4 refers to cluster of differentiation 4.

Measure: CD4 cell count

Time: Day 7 (or day of discharge if before day 7)

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Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Baseline (Day 0)

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Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Day 2

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Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Day 4

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Description: CD8 refers to cluster of differentiation 8.

Measure: CD8 cell count

Time: Day 7 (or day of discharge if before day 7)

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Measure: Natural killer cell count

Time: Baseline (Day 0)

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Measure: Natural killer cell count

Time: Day 2

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Measure: Natural killer cell count

Time: Day 4

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Measure: Natural killer cell count

Time: Day 7 (or day of discharge if before day 7)

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Measure: Activated T cell percentage

Time: Baseline (Day 0)

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Measure: Activated T cell percentage

Time: Day 2

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Measure: Activated T cell percentage

Time: Day 4

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Measure: Activated T cell percentage

Time: Day 7 (or day of discharge if before day 7)

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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)

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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)

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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)

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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)

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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)

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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)

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Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

Measure: Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for grand glass opacities

Time: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

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Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

Measure: Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for consolidation

Time: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

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Description: A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

Measure: Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for total lesions

Time: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

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Measure: Requirement for low flow oxygen therapy during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Requirement for high flow oxygen therapy during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Requirement for non-invasive ventilation during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Requirement for invasive ventilation during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Requirement for dialysis during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Requirement for extracorporeal membrane oxygenation during the initial hospitalisation: yes/no

Time: Day of hospital discharge (expected maximum of 28 days)

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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)

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Measure: Length of stay (hours) in intensive care

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Length of stay (hours) in hospital

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Days alive and without low flow oxygen therapy

Time: Day 28

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Measure: Days alive and without high flow oxygen therapy

Time: Day 28

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Measure: Days alive and without any oxygen therapy

Time: Day 28

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Measure: Days alive and without non-invasive ventilation

Time: Day 28

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Measure: Days alive and without invasive ventilation

Time: Day 28

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Measure: Days alive and without extracorporeal membrane oxygenation

Time: Day 28

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Measure: Days alive and without intensive care

Time: Day 28

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Measure: Days alive and without hospitalisation

Time: Day 28

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Measure: Mortality

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Mortality

Time: Day 28

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Measure: Club cell secrectory protein polymorphism A38G

Time: Between day 0 and day 28

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Other Outcomes

Measure: Presence/absence of incident hyperglycemia during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Presence/absence of secondary infection during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Presence/absence of cardiovascular event (ischemic, stroke, other) during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Presence/absence of digestive hemorrhage during hospitalization

Time: Day of hospital discharge (expected maximum of 28 days)

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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)

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Measure: Adverse events

Time: Day of hospital discharge (expected maximum of 28 days)

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Measure: Adverse events

Time: Day 28

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