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CompletedNCT04469621Updated Sep 23, 2025

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

A Phase 1 interventional study of SAR443122 and Placebo in Corona Virus Infection, sponsored by Sanofi. Completed at 10 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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
Read the detailed description

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

02

Conditions studied

  • Corona Virus Infection
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 68 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant must be ≥18 years and ≤80 years of age inclusive, at the time of signing the informed consent.
  • Hospitalized (or documentation of a plan to admit to the hospital if the participant is in an emergency department) with evidence of COVID-19 lung disease diagnosed by chest radiograph, chest computed tomography or chest auscultation (rales, crackles) and with severe disease defined as follows: The participant requires supplemental oxygen administered by nasal cannula, simple face mask, or other similar oxygen delivery device (ie, increase in oxygen requirement following SARS-CoV-2 infection).
  • SARS-CoV-2 infection confirmed by RT-PCR, or other commercial or public health assay in any specimen, within 3 weeks prior to randomization, and no alternative explanation for current clinical condition.
  • At time of randomization, have demonstrated laboratory signs consistent with systemic inflammation.
  • Male and/or female participants, including women of childbearing potential (WOCBP).
  • Capable of giving signed informed consent.

Exclusion criteria

Exclusion criteria:

  • In the opinion of the investigator, unlikely to survive after 48 hours, or unlikely to remain at the investigational site beyond 48 hours
  • Participants requiring use of invasive or non-invasive positive pressure ventilation at randomization.
  • Presence of significant liver enzyme abnormalities, thrombocytopenia or anemia at screening.
  • Any prior or concurrent use or plans to receive during the study period of immunomodulatory therapies (other than interventional drug) at screening.
  • Use of chronic systemic corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day at screening.
  • Exclusion criteria related to tuberculosis (TB) and non-tuberculous mycobacterial (NTM) infections.
  • Participants with suspected or known active systemic bacterial or fungal infections within 4 weeks of screening.
  • Pregnant or breastfeeding women.
  • In the opinion of the study investigator, might confound the results of the study or pose an undue risk to the safety of the participant.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    SAR443122

    SAR443122 dose 1, twice daily for 14 days

    Drug: SAR443122

  • Placebo comparator
    Placebo

    matching placebo

    Drug: Placebo

Interventions

  • DrugSAR443122

    Pharmaceutical form:capsule Route of administration: oral

  • DrugPlacebo

    Pharmaceutical form:capsule Route of administration: oral

06

What researchers measure

Primary outcomes

  1. Relative change from baseline in CRP level

    Relative change from baseline in CRP level on Day 7

    Time frame: Day 7

Secondary outcomes

  1. Time to 50% decrease from baseline in CRP level

    The time to 50% decrease from baseline in CRP level

    Time frame: Baseline to Day 28

  2. Time to improvement of oxygenation

    The time to improvement of oxygenation as measured by oxygen saturation \>/=92% breathing room air over 48 hrs or until discharge

    Time frame: Baseline to Day 28

  3. Change from baseline in SPO2/FiO2 ratio

    Change from baseline in SPO2/FiO2 ratio at Day 7

    Time frame: Day 7

  4. Number of Days without need for oxygen support and alive

    Number of Days without need for oxygen support and alive (oxygen saturation \>=92% breathing room air) up to Day 28

    Time frame: Baseline to Day 28

  5. Numbers of Ventilator-free days and alive

    Numbers of Ventilator-free days and alive up to Day 28

    Time frame: Baseline to Day 28

  6. Change from baseline in markers of inflammation: white blood cell count and differential blood lymphocytes

    Change from baseline in white blood cell count and differential blood lymphocytes at Day 7 and End of treatment (EOT)

    Time frame: Day 7 and Day 15

  7. Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio

    Change from baseline in neutrophil to lymphocyte ratio at Day 7 and EOT

    Time frame: Day 7 and Day 15

  8. Change from baseline in marker of inflammation: interleukin 6 (IL-6)

    Change from baseline in IL-6 at Day 7 and EOT

    Time frame: Day 7 and Day 15

  9. Change from baseline in D-Dimer

    Change from baseline in D-Dimer at Day 7 and EOT

    Time frame: Day 7 and Day 15

  10. Incidence of Deaths

    Incidence of Deaths up to Day 28

    Time frame: Baseline to Day 28

  11. Percentage of participants receiving thrombolytic treatment

    Percentage of participants receiving thrombolytic treatment up to Day 28

    Time frame: Baseline to Day 28

  12. Percentage of participants receiving vasopressor treatment

    Percentage of participants receiving vasopressor treatment up to Day 28

    Time frame: Baseline to Day 28

  13. Incidence of serious adverse events (SAEs), adverse events of special interest (AESI) and treatment-emergent adverse events (TEAEs) leading to treatment discontinuation

    Time frame: Baseline to Day 28

  14. Incidence of TEAEs leading to study discontinuation (primary reason)

    Time frame: Baseline to Day 28

  15. Numbers of Respiratory Failure-Free Days (RFFD) and alive

    Numbers of Respiratory Failure-Free Days (RFFD) and alive up to Day 28

    Time frame: Baseline to Day 28

07

Study locations

10 sites
  • Investigational Site Number 0320001
    Caba, 1430, Argentina
  • Investigational Site Number 0760003
    Porto Alegre, 90035 003, Brazil
  • Investigational Site Number 0760001
    São José do Rio Preto, 15090-000, Brazil
  • Investigational Site Number 0760002
    São Paulo, 04321-120, Brazil
  • Investigational Site Number 1520001
    Santiago, 750-0691, Chile
  • Investigational Site Number 1520003
    Santiago, 8900085, Chile
  • Investigational Site Number 1520002
    Talca, 3460001, Chile
  • Investigational Site Number 4840001
    Monterrey, 64460, Mexico
  • Investigational Site Number 6430001
    Moscow, 111539, Russia
  • Investigational Site Number 6430002
    Moscow, 123182, Russia
08

References and documents

Publications

  • Clot PF, Farenc C, Suratt BT, Krahnke T, Tardat A, Florian P, Pomponio R, Patel N, Wiekowski M, Lin Y, Terrier B, Staudinger H. Immunomodulatory and clinical effects of receptor-interacting protein kinase 1 (RIPK1) inhibitor eclitasertib (SAR443122) in patients with severe COVID-19: a phase 1b, randomized, double-blinded, placebo-controlled study. Respir Res. 2024 Feb 28;25(1):107. doi: 10.1186/s12931-024-02670-z. PubMed 38419035 ↗

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04469621
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Jul 14, 2020
Start date
Jul 17, 2020
Primary completion
Oct 23, 2020
Completion
Oct 23, 2020
Last update
Sep 23, 2025

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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