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6R88-COV-2040


Title An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients with COVID-19
Therapeutic Area Covid-19
Principal Investigator Andreas Klein
Min Age 18 Years
Gender All
Contact Neely Center for Clinical Cancer Research
By Invitation Only
More Information https://clinicaltrials.gov/ct2/show/NCT04315298

Overview

This study is an adaptive Phase 2/3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of sarilumab in hospitalized adults with severe or critical COVID-19. The study will be conducted in the United States (US) in up to 50 sites. Patients will be randomized in a 2:2:1 ratio to sarilumab 400 mg IV, 200 mg IV, or placebo in a stratified manner. Randomization will be stratified by severity of illness (severe, critical, multi-system organ dysfunction) and use of systemic corticosteroids for COVID-19

Study Details

Inclusion Criteria

  • Hospitalized with illness of any duration with evidence of pneumonia by chest radiograph, chest computed tomography or chest auscultation and fever documented in the medical record and meets at least one of the following at baseline: Severe disease (requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device), Critical disease (requires supplemental oxygen delivered by non-rebreather mask or high-flow nasal cannula), use of invasive or non-invasive ventilation, or requiring treatmenet in an intensive care unit.
  • Laboratory confirmed SARS-CoV-2 infection as determined by a PCR result from any specimen within 2 weeks prior to randomization and no alternative explanation for current clinical condition
  • Willing and/pr able to comply with study-related procedures/assessments

Exclusion Criteria

  • Treatment with anti-IL-6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plan to receive during the study protocol
  • Current treatment with the following conventional synthetic DMARDs/immunosuppressive agents including: MTX, cyclosporine, mycophenolate, tacrolimus, gold, pencillamine, or sulfasalazine within 2 weeks prior to randomization; azathioprine or cyclophosphamide within 12 weeks prior to randomization; Leflunomide within 8 weeks prior to randomization.
  • Use of chronic oral corticosteroids (>3 months in duration) for a non-COVID-19-related condition in a dose higher than prednisone 10mg or equivalent per day.

Study Requirements

Length of hospitalization is estimated to last ~29 days. During the hospitalization patients will have blood drawn daily for laboratory results.