NCT04469621

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Corona Virus Infection

Interventions

Type	Name	Description
DRUG	SAR443122	Pharmaceutical form:capsule Route of administration: oral
DRUG	Placebo	Pharmaceutical form:capsule Route of administration: oral

Timeline

• Start date: 2020-07-17
• Primary completion: 2020-10-23
• Completion: 2020-10-23
• First posted: 2020-07-14
• Last updated: 2025-09-23

Locations

10 sites across 5 countries: Argentina, Brazil, Chile, Mexico, Russia