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The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.
Enrollment
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Inclusion criteria
Patients included in the CORIMUNO-19 cohort (NCT04324047)
COVID-19 cases not requiring ICU at admission with moderate or severe pneumopathy according to the WHO Criteria of severity of COVID pneumopathy:
Exclusion criteria
Patients with exclusion criteria to the CORIMUNO-19 cohort.
Respiratory failure requiring non invasive or mechanical ventilation
Patients requiring intensive care
Do-not-resuscitate order (DNR order)
Known hypersensitivity to sarilumab or to any of their excipients.
Known contra-indication to hydroxychloroquine or chloroquine: including hypersensitivity/allergy, retinopathy, G6PD deficiency and QT prolongation
Known contra-indication to azithromycin: including hypersensitivity/allergy and QT prolongation
Pregnancy or breastfeeding
Current documented bacterial infection.
Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:
Primary purpose
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Interventional model
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27 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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