Name (Synonyms) | Correlation | |
---|---|---|
drug3018 | survey Wiki | 0.41 |
drug1822 | Placebo Wiki | 0.06 |
Name (Synonyms) | Correlation | |
---|---|---|
D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
Primary Objective: To evaluate the effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by C-reactive protein (CRP) levels in adult patients hospitalized with severe COVID-19 Secondary Objectives: - To evaluate the time to onset of effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by CRP levels - To evaluate the time to onset of effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on total duration of supplemental oxygen requirement - To evaluate the effect of SAR443122 relative to the control arm on length of ventilator support needed - To evaluate the effect of SAR443122 relative to the control arm on laboratory markers of severe COVID-19 - To evaluate the effect of SAR443122 relative to the control arm on mortality - To evaluate the effect of SAR443122 relative to the control arm on need for thrombolytic therapy - To evaluate the effect of SAR443122 relative to the control arm on need for vasopressor treatment - To evaluate the safety of SAR443122 as compared to the control arm up to End of Study
Description: Relative change from baseline in CRP level on Day 7
Measure: Relative change from baseline in CRP level Time: Day 7Description: The time to 50% decrease from baseline in CRP level
Measure: Time to 50% decrease from baseline in CRP level Time: Baseline to Day 28Description: The time to improvement of oxygenation as measured by oxygen saturation >/=92% breathing room air over 48 hrs or until discharge
Measure: Time to improvement of oxygenation Time: Baseline to Day 28Description: Change from baseline in SPO2/FiO2 ratio at Day 7
Measure: Change from baseline in SPO2/FiO2 ratio Time: Day 7Description: Number of Days without need for oxygen support and alive (oxygen saturation >=92% breathing room air) up to Day 28
Measure: Number of Days without need for oxygen support and alive Time: Baseline to Day 28Description: Numbers of Ventilator-free days and alive up to Day 28
Measure: Numbers of Ventilator-free days and alive Time: Baseline to Day 28Description: Change from baseline in white blood cell count and differential blood lymphocytes at Day 7 and End of treatment (EOT)
Measure: Change from baseline in markers of inflammation: white blood cell count and differential blood lymphocytes Time: Day 7 and Day 15Description: Change from baseline in neutrophil to lymphocyte ratio at Day 7 and EOT
Measure: Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio Time: Day 7 and Day 15Description: Change from baseline in IL-6 at Day 7 and EOT
Measure: Change from baseline in marker of inflammation: interleukin 6 (IL-6) Time: Day 7 and Day 15Description: Change from baseline in D-Dimer at Day 7 and EOT
Measure: Change from baseline in D-Dimer Time: Day 7 and Day 15Description: Incidence of Deaths up to Day 28
Measure: Incidence of Deaths Time: Baseline to Day 28Description: Percentage of participants receiving thrombolytic treatment up to Day 28
Measure: Percentage of participants receiving thrombolytic treatment Time: Baseline to Day 28Description: Percentage of participants receiving vasopressor treatment up to Day 28
Measure: Percentage of participants receiving vasopressor treatment Time: Baseline to Day 28