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

COVID-19 Clinical Trial

— ARCHITECTS  

Official title:

A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Tocilizumab for the Treatment of Severe COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04412772
• Other study ID #: RA-2020-019
• Status: Recruiting
• Phase: Phase 3
• Start date: June 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Queen's Medical Centre
• Contact: Todd Seto, MD
• Phone: 808 354-3533
• Email: tseto[@]queens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Tocilizumab
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.
• Placebo
Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.

Locations

Country	Name	City	State
United States	Queen's Medical Center	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Queen's Medical Centre

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical status (on a 7-point ordinal scale) at day 28	Clinical Status 7-point ordinal scale: Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death	up to day 28
Secondary	Clinical improvement	ii. Time to clinical improvement, defined as a National Early Warning Score (NEWS) of < 2 maintained for 24 hours iii. Time to clinical improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status	up to day 28
Secondary	Mechanical Ventilation	iv. Incidence of mechanical ventilation v. Ventilator-free days	up to day 28
Secondary	Oxygenation	vi. Duration of time on supplemental oxygen	up to day 28