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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
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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