A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: Remdesivir; Tocilizumab; Placebo
Intervention description: Participants will receive intravenous (IV) RDV; Participants will receive IV TCZ; Participants will receive IV placebo matched to TCZ
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 649.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of combination therapy with remdesivir plus
      tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19
      pneumonia.
    

Eligibility criteria:

        Inclusion Criteria

          -  Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain
             reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily
             fluid) and evidenced by chest X-ray or CT scan

          -  Requiring more than 6 L/min supplemental oxygen to maintain SpO2 > 93%

          -  Agrees to not participate in another clinical trial for the treatment of COVID-19
             while participating in this study

        Exclusion Criteria

          -  Known severe allergic reactions to tocilizumab or other monoclonal antibodies

          -  Known hypersensitivity to remdesivir, the metabolites, or formulation excipients

          -  Active tuberculosis (TB) infection

          -  Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)

          -  In the opinion of the investigator, progression to death is imminent and inevitable
             within the next 24 hours, irrespective of the provision of treatments

          -  Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab)
             within the past 3 months

          -  Concurrent treatment with other agents with actual or possible direct-acting antiviral
             activity against SARS-CoV-2 within 24 hours prior to study drug dosing. In addition,
             participants with prior or current treatment with > 2 doses of remdesivir for COVID-19
             are excluded

          -  Participating in other drug clinical trials

          -  Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving
             hemodialysis or hemofiltration)

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit
             of normal (ULN) detected within 24 hours of screening (according to local laboratory
             reference ranges)

          -  Absolute neutrophil count (ANC) < 1000/uL at screening

          -  Platelet count < 50,000/uL at screening

          -  Body weight < 40 kg

          -  Treatment with an investigational drug within 5 half-lives or 30 days (whichever is
             longer) of randomization