Status:
UNKNOWN
Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS
Lead Sponsor:
Queen's Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18-95 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04412772
Start Date
June 12 2020
End Date
December 31 2021
Last Update
November 17 2020
Active Locations (1)
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1
Queen's Medical Center
Honolulu, Hawaii, United States, 96813