Evaluation Of The Efficacy And Safety Of Sarilumab In Hospitalized Patients With COVID-19 (Enrollment By Invitation Only)

Overview

About this study

Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19.

Phase 3: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female adult ≥ 18 years of age at time of enrollment.
  • Hospitalized (or documentation of a plan to admit to the hospital if the patient is in an emergency department) with illness of any duration with evidence of pneumonia by chest radiograph, chest computed tomography or chest auscultation (rales, crackles) and fever documented in the medical record and meets at least one of the following at baseline (patients meeting more than one criterion will be categorized in the most severely affected category).
    • Severe disease:
      • Requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device (i.e., above pre-COVID baseline requirement, if any, by the patient).
    • Critical disease:
      • Requires supplemental oxygen delivered by non-rebreather mask or high-flow nasal cannula; OR
      • Use of invasive or non-invasive ventilation;
      • Requiring treatment in an intensive care unit.
    • Multi-system organ dysfunction: use of vasopressors, extracorporeal life support, or renal replacement therapy.
  • Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization.
  • Willing and/or able to comply with study-related procedures/assessments.
  • Provide informed consent signed by study patient or legally acceptable representative

Exclusion Criteria:

  • In the opinion of the investigator, unlikely to survive for > 48 hours from screening.
  • Presence of any of the following abnormal laboratory values at screening:
    • absolute neutrophil count (ANC) less than 2,000 mm^3;
    • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN);
    • platelets < 50,000 per mm^3.
  • Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period.
  • Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents including:
    • MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, or sulfasalazine within 2 weeks prior to randomization;
    • Azathioprine or cyclophosphamide within 12 weeks prior to randomization;
    • Leflunomide within 8 weeks prior to randomization. Patients who have undergone standard cholestyramine washout may qualify if it is done at least 4 weeks before randomization: cholestyramine at a dosage of 8 g three times daily for at least 24 hours, or activated charcoal at a dosage of 50 g 4 times a day for at least 24 hours.
  • Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
  • Past history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.
  • Exclusion criteria related to tuberculosis (TB):
    • Known active TB or a history of incompletely treated TB;
    • Suspected or known extrapulmonary tuberculosis.
  • Patients with suspected or known active systemic bacterial or fungal infections.
  • Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin or plans to receive during the study period.
  • Participation in any clinical research study, including any double-blind study, evaluating an investigational product or therapy within 3 months and less than 5 half-lives of investigational product prior to the screening visit:
    • The use of remdisivir in the context of a single-arm remdisivir compassionate use protocol is permitted.
  • Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Raymund Razonable, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Department of Medicine (DOM) Research Hub

(507) 266-1944

DOMRESEARCHHUB@mayo.edu

More information

Publications

Publications are currently not available