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

NCT ID: NCT04469621

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2020-10-23

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

Conditions

Corona Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAR443122

SAR443122 dose 1, twice daily for 14 days

Group Type: EXPERIMENTAL

SAR443122

Intervention Type: DRUG

Pharmaceutical form:capsule Route of administration: oral

Placebo

matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form:capsule Route of administration: oral

Interventions

SAR443122

Pharmaceutical form:capsule Route of administration: oral

Intervention Type: DRUG

Placebo

Pharmaceutical form:capsule Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 0320001

Caba, , Argentina

Investigational Site Number 0760003

Porto Alegre, , Brazil

Investigational Site Number 0760001

São José do Rio Preto, , Brazil

Investigational Site Number 0760002

São Paulo, , Brazil

Investigational Site Number 1520001

Santiago, , Chile

Investigational Site Number 1520003

Santiago, , Chile

Investigational Site Number 1520002

Talca, , Chile

Investigational Site Number 4840001

Monterrey, , Mexico

Investigational Site Number 6430001

Moscow, , Russia

Investigational Site Number 6430002

Moscow, , Russia

Countries

Argentina; Brazil; Chile; Mexico; Russia

References

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.

Reference Type: DERIVED

PMID: 38419035 (View on PubMed)

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25318&tenant=MT_SNY_9011

PDY16879 Plain Language Results Summary

Other Identifiers

2020-002104-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1250-1185

Identifier Type: OTHER

Identifier Source: secondary_id

PDY16879

Identifier Type: -

Identifier Source: org_study_id