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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Corona Virus Infection

Treatments: Drug: Placebo; Drug: SAR443122

Study type: Interventional

Funder types: Industry

Identifiers

NCT04469621

U1111-1250-1185 (Other Identifier)

2020-002104-39 (EudraCT Number)

PDY16879

Details and patient eligibility

About

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

Full description

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

Enrollment: 68 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

SAR443122

Experimental group

Description:

SAR443122 dose 1, twice daily for 14 days

Treatment:

Drug: SAR443122

Placebo

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: Placebo