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

NCT04469621 | Completed Phase 1 DMC

• 3 other identifiers: PDY168792020-002104-39U1111-1250-1185
• Study Type: interventional
• Target: 68
• Locations: 5 countries
• Sites: 10

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

Conditions

Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in CRP level

  Relative change from baseline in CRP level on Day 7

  Day 7

Secondary Outcomes (15)

• Time to 50% decrease from baseline in CRP level

  Baseline to Day 28

• Time to improvement of oxygenation

  Baseline to Day 28

• Change from baseline in SPO2/FiO2 ratio

  Day 7

• Number of Days without need for oxygen support and alive

  Baseline to Day 28

• Numbers of Ventilator-free days and alive

  Baseline to Day 28

Study Arms (2)

SAR443122

EXPERIMENTAL

SAR443122 dose 1, twice daily for 14 days

Drug: SAR443122

Placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

SAR443122 DRUG

Pharmaceutical form:capsule Route of administration: oral

SAR443122

Placebo DRUG

Pharmaceutical form:capsule Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (10)

Investigational Site Number 0320001

Caba, 1430, Argentina

Location

Investigational Site Number 0760003

Porto Alegre, 90035 003, Brazil

Location

Investigational Site Number 0760001

São José do Rio Preto, 15090-000, Brazil

Location

Investigational Site Number 0760002

São Paulo, 04321-120, Brazil

Location

Investigational Site Number 1520001

Santiago, 750-0691, Chile

Location

Investigational Site Number 1520003

Santiago, 8900085, Chile

Location

Investigational Site Number 1520002

Talca, 3460001, Chile

Location

Investigational Site Number 4840001

Monterrey, 64460, Mexico

Location

Investigational Site Number 6430001

Moscow, 111539, Russia

Location

Investigational Site Number 6430002

Moscow, 123182, Russia

Location

Related Publications (1)

• 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.

  PMID: 38419035 DERIVED

Related Links

• PDY16879 Plain Language Results Summary

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 14, 2020
• Study Start: July 17, 2020
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CL (3); AR (1); RU (2); ME (1); BR (3)