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

NCT04469621 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-09-23

No results posted yet for this study

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

Conditions

  • Corona Virus Infection

Interventions

DRUG

SAR443122

Pharmaceutical form:capsule Route of administration: oral

DRUG

Placebo

Pharmaceutical form:capsule Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2020-10-23
Completion
2020-10-23

Countries

  • Argentina
  • Brazil
  • Chile
  • Mexico
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469621 on ClinicalTrials.gov