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

  • COVID-19 Pneumonia
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT04363736 CA42481

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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

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