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

  • 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
Countries
  • Brazil
  • Russia
  • Spain
  • United States
Trial Identifier:

NCT04409262 2020-002275-34 WA42511

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

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04409262, WA42511, 2020-002275-34 Trial Identifier
      Remdesivir, Tocilizumab, Placebo Treatments
      COVID-19 Pneumonia Condition
      Official Title

      A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia

      Eligibility Criteria

      All Gender
      ≥12 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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