Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04469621
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2020-06-28
Brief Title:
A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 1b Randomized Double-blinded Placebo-controlled Study to Evaluate the Safety and Immunomodulatory Effect of the RIPK1 Inhibitor SAR443122 in Hospitalized Patients With Severe COVID-19
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Study duration per participant is approximatively 32 days including a 14-day treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002104-39 | EUDRACT_NUMBER | None | None |
| U1111-1250-1185 | OTHER | UTN | None |