Eine Studie zur Beurteilung der Sicherheit und Wirksamkeit von Tocilizumab bei Patient*innen mit schwerer COVID-19-Lungenentzündung

A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)

  • Infektionskrankheiten
  • COVID-19 Pneumonie
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:

Abgeschlossen

Diese Studie läuft in
Städte
  • Düsseldorf
  • Hannover
  • Köln
  • München
Studien-ID:

NCT04320615 2020-001154-22 WA42380

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04320615, WA42380, 2020-001154-22 Studien-ID
      Tocilizumab (TCZ), Placebo Treatments
      COVID-19 Pneumonia Condition
      Official Title

      A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

      Einschlusskriterien

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
      • SPO2 </=93% or PaO2/FiO2 <300 mmHg
      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 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
      • Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
      • Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
      • Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
      • Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor)
      • Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
      • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
      • Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab)
      • Platelet count < 50,000/mL at screening (per local lab)

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