A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: Tociliuzumab
Intervention description: Participants will receive IV TCZ.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two
      different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in
      hospitalized adult participants with moderate to severe COVID-19 pneumonia.
    

Eligibility criteria:

        Inclusion Criteria

          -  Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain
             reaction (PCR) of any specimen [e.g., respiratory, blood, urine, stool, and other
             bodily fluids]) and evidence of pneumonia on chest X-ray or computed tomography scan

          -  For severe patients, SpO2 </= 93% or PaO2/FiO2 < 300 mmHg. If a participant is on
             supplemental oxygen with SpO2 > 93%, but desaturation </= to 93% on lower supplemental
             oxygen or ambient air is documented during screening, the inclusion criterion is met

          -  For moderate patients (those who do not qualify as severe based oxygen requirements),
             CRP > 2 x upper limit of normal (ULN) is required

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraception, as defined by the protocol

          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             a condom, and agreement to refrain from donating sperm, as defined by the protocol

        Exclusion Criteria

          -  Known severe allergic reactions to TCZ or other monoclonal antibodies

          -  Active tuberculosis (TB) infection

          -  Suspected active bacterial, fungal, viral, or other infection (besides SARS-CoV-2)

          -  Participants who are on a mechanical ventilator > 24 hours or extracorporeal membrane
             oxygenation (ECMO), in shock, or combination thereof with other organ failure
             requiring treatment in an ICU

          -  In the opinion of the investigator, progression to death is imminent and inevitable
             within the next 24 hours, irrespective of the provision of treatments

          -  Receipt of oral anti-rejection or immunomodulatory drugs (including TCZ) within the
             past 3 months

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x ULN detected
             within 24 hours at screening or at baseline (according to local laboratory reference
             ranges)

          -  Absolute neutrophil count (ANC) < 1000/uL at screening and baseline (according to
             local laboratory reference ranges)

          -  Platelet count < 50,000/uL at screening and baseline (according to local laboratory
             reference ranges)

          -  Pregnancy or breastfeeding, or positive pregnancy test at a predose examination

          -  Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days
             (whichever is longer) of randomization