We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469621
Recruitment Status : Completed
First Posted : July 14, 2020
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: SAR443122 Drug: Placebo Phase 1

Detailed Description:
Study duration per participant is approximatively 32 days including a 14-day treatment period
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 17, 2020
Actual Primary Completion Date : October 23, 2020
Actual Study Completion Date : October 23, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SAR443122
SAR443122 dose 1, twice daily for 14 days
 Drug: SAR443122
Pharmaceutical form:capsule Route of administration: oral
Placebo Comparator: Placebo
matching placebo
 Drug: Placebo
Pharmaceutical form:capsule Route of administration: oral


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Relative change from baseline in CRP level [ Time Frame: Day 7 ]
    Relative change from baseline in CRP level on Day 7


Secondary Outcome Measures :
  1. Time to 50% decrease from baseline in CRP level [ Time Frame: Baseline to Day 28 ]
    The time to 50% decrease from baseline in CRP level

  2. Time to improvement of oxygenation [ Time Frame: Baseline to Day 28 ]
    The time to improvement of oxygenation as measured by oxygen saturation >/=92% breathing room air over 48 hrs or until discharge

  3. Change from baseline in SPO2/FiO2 ratio [ Time Frame: Day 7 ]
    Change from baseline in SPO2/FiO2 ratio at Day 7

  4. Number of Days without need for oxygen support and alive [ Time Frame: Baseline to Day 28 ]
    Number of Days without need for oxygen support and alive (oxygen saturation >=92% breathing room air) up to Day 28

  5. Numbers of Ventilator-free days and alive [ Time Frame: Baseline to Day 28 ]
    Numbers of Ventilator-free days and alive up to Day 28

  6. 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 white blood cell count and differential blood lymphocytes at Day 7 and End of treatment (EOT)

  7. Change from baseline in marker of inflammation: neutrophil to lymphocyte ratio [ Time Frame: Day 7 and Day 15 ]
    Change from baseline in neutrophil to lymphocyte ratio at Day 7 and EOT

  8. Change from baseline in marker of inflammation: interleukin 6 (IL-6) [ Time Frame: Day 7 and Day 15 ]
    Change from baseline in IL-6 at Day 7 and EOT

  9. Change from baseline in D-Dimer [ Time Frame: Day 7 and Day 15 ]
    Change from baseline in D-Dimer at Day 7 and EOT

  10. Incidence of Deaths [ Time Frame: Baseline to Day 28 ]
    Incidence of Deaths up to Day 28

  11. Percentage of participants receiving thrombolytic treatment [ Time Frame: Baseline to Day 28 ]
    Percentage of participants receiving thrombolytic treatment up to Day 28

  12. Percentage of participants receiving vasopressor treatment [ Time Frame: Baseline to Day 28 ]
    Percentage of participants receiving vasopressor treatment up 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 [ Time Frame: Baseline to Day 28 ]
    Numbers of Respiratory Failure-Free Days (RFFD) and alive up to Day 28


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469621


Locations
Layout table for location information
Argentina
Investigational Site Number 0320001
Caba, Argentina, 1430
Brazil
Investigational Site Number 0760003
Porto Alegre, Brazil, 90035 003
Investigational Site Number 0760001
São José Do Rio Preto, Brazil, 15090-000
Investigational Site Number 0760002
São Paulo, Brazil, 04321-120
Chile
Investigational Site Number 1520001
Santiago, Chile, 750-0691
Investigational Site Number 1520003
Santiago, Chile, 8900085
Investigational Site Number 1520002
Talca, Chile, 3460001
Mexico
Investigational Site Number 4840001
Monterrey, Mexico, 64460
Russian Federation
Investigational Site Number 6430001
Moscow, Russian Federation, 111539
Investigational Site Number 6430002
Moscow, Russian Federation, 123182
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04469621    
Other Study ID Numbers: PDY16879
2020-002104-39 ( EudraCT Number )
U1111-1250-1185 ( Other Identifier: UTN )
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Virus Diseases
Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections