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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's Medical Centre

Criteria

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