A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19
Status:
Completed
Trial end date:
2020-10-23
Target enrollment:
Participant gender:
Summary
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 coronavirus disease 2019 (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
- To evaluate the effect of SAR443122 relative to the control arm on total duration
without high flow supplemental oxygen requirements