A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia

  • Infectious Diseases
  • COVID-19 Pneumonia
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • United States
Trial Identifier:

NCT04363736 CA42481

  • Mayo Clinic - Arizona

    85054PhoenixUnited States
  • St. Jude Medical Center

    92835FullertonUnited States
  • LAC + USC Medical Center

    90033Los AngelesUnited States
  • USC Keck Medical Center of USC

    90033Los AngelesUnited States
  • Norwalk Hospital

    06856NorwalkUnited States
  • Medstar Georgetown University Hospital

    20007WashingtonUnited States
  • Mayo Clinic

    32224JacksonvilleUnited States
  • Advocate Christ Medical Center

    60453Oak LawnUnited States
  • Advocate Lutheran General Hospital

    60068Park RidgeUnited States
  • University of Maryland

    21201BaltimoreUnited States
  • Renown Institute for Heart & Vascular Health

    89502RenoUnited States
  • St Joseph's Regional Medical Center

    07503patersonUnited States
  • SUNY Downstate Medical Center.

    11203New YorkUnited States
  • Jamaica Hospital Medical Center

    11418New YorkUnited States
  • Wake Forest University Health Sciences

    27109Winston-SalemUnited States
  • University Hospitals Cleveland Medical Center

    44106ClevelandUnited States
  • Mercy St. Vincent Medical Center

    43608ToledoUnited States
  • Lehigh Valley Health Network

    18103AllentownUnited States
  • Temple University Hospital

    19140PhiladelphiaUnited States
  • Allegheny Health Network (Pittsburg PA)

    15212PittsburghUnited States
  • Medical University of South Carolina

    29425CharlestonUnited States
  • Houston Methodist Hospital

    77030HoustonUnited States
  • Michael E. DeBakey VA Medical Center

    77030HoustonUnited States
  • Houston Methodist Sugar Land Hospital

    77479Sugar LandUnited States
    Show trial locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Trial 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.

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT04363736, CA42481 Trial Identifier
    Tociliuzumab Treatments
    COVID-19 Pneumonia Condition
    Official Title

    A Phase-II, Open-Label, Randomized, Multicenter Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of 8 mg/kg or 4mg/kg Intravenous Tocilizumab in Patients With Moderate to Severe COVID-19 Pneumonia

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    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

    Clinical Research Explained

    Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

    Find out now