A RCT - Safety & Efficacy of Tocilizumab - Tx of Severe COVID-19: ARCHITECTS

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Queen's Medical Centre
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Updated on 16 February 2024
See if I qualify
ct scan
shock
vasopressor
mechanical ventilation
pao2
FIO2
interleukin-6
x-rays
pneumonia
respiratory distress
acute respiratory distress syndrome
covid-19
chest x-ray
fungal infection
vasoconstrictor
tocilizumab
extracorporeal membrane oxygenation
acute respiratory distress
fraction of inspired oxygen (fio2)
extracorporeal membrane oxygenation (ecmo)

Summary

The overall objective is to evaluate the clinical efficacy and safety of tocilizumab relative to placebo among approximately 300 hospitalized adult patients who have severe COVID-19. The study will be a 2 arm double blinded comparison between tocilizumab 8 mg/kg and matching placebo IV. The dose may be repeated in 8-12 hours if clinical symptoms worsens, (e.g. increase in oxygen requirements). Participants will be followed for 28 days.

Details
Condition Covid 19
Age 18years - 95years
Treatment Placebo, Tocilizumab
Clinical Study IdentifierNCT04412772
SponsorQueen's Medical Centre
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

ii. Hospitalized with COVID-19 pneumonia, based on chest X-ray or CT scan AND iii. Evidence of hyperinflammation: IL-6>40pg/mL (if available) OR CRP >2 mg/dL OR ferritin >2000 ng/mL AND iv. One or more of the following: impending need for requiring invasive or non-invasive mechanical ventilation OR shock requiring vasopressor (without evidence of bacterial / fungal infection) OR need for extracorporeal membrane oxygenation (ECMO) OR severe, refractor ARDS (PaO2/FiO2<200 mmHg)

Exclusion Criteria

Known severe allergic reactions to tocilizumab or other monoclonal antibodies
Active tuberculosis infection based on history
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 tocilizumab) with the past 6 months
Participating in other drug clinical trials (participation in COVID-19 trials allowed)
Self-reported pregnant or breastfeeding
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 baseline
Absolute neutrophil count (ANC) < 1000/mL at baseline
Platelet count < 50,000/mL at baseline
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ct scan
shock
vasopressor
mechanical ventilation
pao2
FIO2
interleukin-6
x-rays
pneumonia
respiratory distress
acute respiratory distress syndrome
covid-19
chest x-ray
fungal infection
vasoconstrictor
tocilizumab
extracorporeal membrane oxygenation
acute respiratory distress
fraction of inspired oxygen (fio2)
extracorporeal membrane oxygenation (ecmo)

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