Corona Virus InfectionPhase 1NCT04469621
A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19
A Phase 1 study testing SAR443122 in people with Corona Virus Infection, run by Sanofi at 10 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- SAR443122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 17 Jul 2020to 23 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Brazil3 sites
Investigational Site Number 0760003
Porto Alegre, 90035 003
Investigational Site Number 0760001
São José do Rio Preto, 15090-000
Investigational Site Number 0760002
São Paulo, 04321-120
Chile3 sites
Investigational Site Number 1520001
Santiago, 750-0691
Investigational Site Number 1520003
Santiago, 8900085
Investigational Site Number 1520002
Talca, 3460001
Russia2 sites
Investigational Site Number 6430001
Moscow, 111539
Investigational Site Number 6430002
Moscow, 123182
About this study
Official title: 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
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)
Read more
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
- Conditions
- Corona Virus Infection
- Being tested
- SAR443122, Placebo
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR443122Drug
Pharmaceutical form:capsule Route of administration: oral
PlaceboDrug
Pharmaceutical form:capsule Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| SAR443122 | Experimental | SAR443122 dose 1, twice daily for 14 days Receives: Drug: SAR443122 |
| Placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in CRP level
Relative change from baseline in CRP level on Day 7
Measured: Day 7
Secondary outcomes (15)
Time to 50% decrease from baseline in CRP level
The time to 50% decrease from baseline in CRP level
Measured: Baseline to Day 28
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
Measured: Baseline to Day 28
Change from baseline in SPO2/FiO2 ratio
Change from baseline in SPO2/FiO2 ratio at Day 7
Measured: Day 7
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
Measured: Baseline to Day 28
Numbers of Ventilator-free days and alive
Numbers of Ventilator-free days and alive up to Day 28
Measured: Baseline to Day 28
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)
Measured: Day 7 and Day 15
Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio
Change from baseline in neutrophil to lymphocyte ratio at Day 7 and EOT
Measured: Day 7 and Day 15
Change from baseline in marker of inflammation: interleukin 6 (IL-6)
Change from baseline in IL-6 at Day 7 and EOT
Measured: Day 7 and Day 15
Change from baseline in D-Dimer
Change from baseline in D-Dimer at Day 7 and EOT
Measured: Day 7 and Day 15
Incidence of Deaths
Incidence of Deaths up to Day 28
Measured: Baseline to Day 28
Percentage of participants receiving thrombolytic treatment
Percentage of participants receiving thrombolytic treatment up to Day 28
Measured: Baseline to Day 28
Percentage of participants receiving vasopressor treatment
Percentage of participants receiving vasopressor treatment up to Day 28
Measured: Baseline to Day 28
Incidence of serious adverse events (SAEs), adverse events of special interest (AESI) and treatment-emergent adverse events (TEAEs) leading to treatment discontinuation
Measured: Baseline to Day 28
Incidence of TEAEs leading to study discontinuation (primary reason)
Measured: Baseline to Day 28
Numbers of Respiratory Failure-Free Days (RFFD) and alive
Numbers of Respiratory Failure-Free Days (RFFD) and alive up to Day 28
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start17 Jul 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469621
- Sponsor's protocol ID
- PDY16879
- Other IDs
- 2020-002104-39, U1111-1250-1185
- Status last verified
- Sep 2025
- First submitted
- 28 Jun 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04469621
- Acronym / sponsor ID
- PDY16879
- Conditions
- Corona Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR443122 | Experimental | Drug: SAR443122SAR443122 dose 1, twice daily for 14 days |
| Placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR443122Pharmaceutical form:capsule Route of administration: oral | Drug | SAR443122 |
| PlaceboPharmaceutical form:capsule Route of administration: oral | Drug | Placebo |
Primary outcome
Relative change from baseline in CRP level
Time frame: Day 7
Relative change from baseline in CRP level on Day 7
15 secondary outcomes
Time to 50% decrease from baseline in CRP level
Time frame: Baseline to Day 28
Time to improvement of oxygenation
Time frame: Baseline to Day 28
Change from baseline in SPO2/FiO2 ratio
Time frame: Day 7
Number of Days without need for oxygen support and alive
Time frame: Baseline to Day 28
Numbers of Ventilator-free days and alive
Time frame: Baseline to Day 28
Change from baseline in markers of inflammation: white blood cell count and differential blood lymphocytes
Time frame: Day 7 and Day 15
Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio
Time frame: Day 7 and Day 15
Change from baseline in marker of inflammation: interleukin 6 (IL-6)
Time frame: Day 7 and Day 15
Change from baseline in D-Dimer
Time frame: Day 7 and Day 15
Incidence of Deaths
Time frame: Baseline to Day 28
Percentage of participants receiving thrombolytic treatment
Time frame: Baseline to Day 28
Percentage of participants receiving vasopressor treatment
Time frame: Baseline to Day 28
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
Incidence of TEAEs leading to study discontinuation (primary reason)
Time frame: Baseline to Day 28
Numbers of Respiratory Failure-Free Days (RFFD) and alive
Time frame: Baseline to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Derived from this study: PubMed 38419035Clot 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.
- PDY16879 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR443122 in people with Corona Virus Infection, run by Sanofi at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil, Chile, Russia, Argentina, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change from baseline in CRP level (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.