Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04412772

Run by

Queen's Medical Center

People needed

20

Starts

2020-06-12

Expected to finish

2021-03-31

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Queen's Medical Center — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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