A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19

Phase 1

Completed

• Conditions: Corona Virus Infection
• Interventions: Drug: Placebo; Drug: SAR443122

• Registration Number: NCT04469621
• Lead Sponsor: Sanofi

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

Detailed Description

Study duration per participant is approximatively 32 days including a 14-day treatment period

Study Timeline

• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-14
• Study Start: 2020-07-17
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	matching placebo
SAR443122	SAR443122	SAR443122 dose 1, twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
Relative change from baseline in CRP level	Day 7	Relative change from baseline in CRP level on Day 7

Secondary Outcome Measures

Name	Time	Method
Time to 50% decrease from baseline in CRP level	Baseline to Day 28	The time to 50% decrease from baseline in CRP level
Time to improvement of oxygenation	Baseline to Day 28	The time to improvement of oxygenation as measured by oxygen saturation \>/=92% breathing room air over 48 hrs or until discharge
Change from baseline in SPO2/FiO2 ratio	Day 7	Change from baseline in SPO2/FiO2 ratio at Day 7
Number of Days without need for oxygen support and alive	Baseline to Day 28	Number of Days without need for oxygen support and alive (oxygen saturation \>=92% breathing room air) up to Day 28
Numbers of Ventilator-free days and alive	Baseline to Day 28	Numbers of Ventilator-free days and alive up to Day 28
Change from baseline in markers of inflammation: white blood cell count and differential blood lymphocytes	Day 7 and Day 15	Change from baseline in white blood cell count and differential blood lymphocytes at Day 7 and End of treatment (EOT)
Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio	Day 7 and Day 15	Change from baseline in neutrophil to lymphocyte ratio at Day 7 and EOT
Change from baseline in marker of inflammation: interleukin 6 (IL-6)	Day 7 and Day 15	Change from baseline in IL-6 at Day 7 and EOT
Change from baseline in D-Dimer	Day 7 and Day 15	Change from baseline in D-Dimer at Day 7 and EOT
Incidence of Deaths	Baseline to Day 28	Incidence of Deaths up to Day 28
Percentage of participants receiving thrombolytic treatment	Baseline to Day 28	Percentage of participants receiving thrombolytic treatment up to Day 28
Percentage of participants receiving vasopressor treatment	Baseline to Day 28	Percentage of participants receiving vasopressor treatment up to Day 28
Incidence of serious adverse events (SAEs), adverse events of special interest (AESI) and treatment-emergent adverse events (TEAEs) leading to treatment discontinuation	Baseline to Day 28
Incidence of TEAEs leading to study discontinuation (primary reason)	Baseline to Day 28
Numbers of Respiratory Failure-Free Days (RFFD) and alive	Baseline to Day 28	Numbers of Respiratory Failure-Free Days (RFFD) and alive up to Day 28

Trial Locations

Locations (10)

Investigational Site Number 0320001; 🇦🇷 Caba, Argentina

Investigational Site Number 1520003; 🇨🇱 Santiago, Chile

Investigational Site Number 6430002; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 0760002; 🇧🇷 São Paulo, Brazil

Investigational Site Number 0760001; 🇧🇷 São José Do Rio Preto, Brazil

Investigational Site Number 6430001; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 1520001; 🇨🇱 Santiago, Chile

Investigational Site Number 0760003; 🇧🇷 Porto Alegre, Brazil

Investigational Site Number 1520002; 🇨🇱 Talca, Chile

Investigational Site Number 4840001; 🇲🇽 Monterrey, Mexico