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Tocilizumab for COVID-19 (ARCHITECTS Trial)
Phase 3
Waitlist Available
Led By Todd Seto, MD
Research Sponsored by Queen's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 28
Awards & highlights
ARCHITECTS Trial Summary
This trial will compare the effects of tocilizumab versus placebo in 300 adults hospitalized with severe COVID-19. Tocilizumab is given as an IV infusion, and the dose may be repeated if symptoms worsen. Participants will be followed for 28 days.
Eligible Conditions
- COVID-19
- Coronavirus
ARCHITECTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowARCHITECTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical status (on a 7-point ordinal scale) at day 28
Secondary outcome measures
Clinical improvement
Mechanical ventilation
Oxygenation
Side effects data
From 2017 Phase 4 trial • 59 Patients • NCT0203447411%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo
ARCHITECTS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tocilizumab (TCZ) ArmExperimental Treatment1 Intervention
Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen.
Group II: Placebo ArmPlacebo Group1 Intervention
Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved
Find a Location
Who is running the clinical trial?
Queen's Medical CenterLead Sponsor
21 Previous Clinical Trials
4,562 Total Patients Enrolled
1 Trials studying COVID-19
17 Patients Enrolled for COVID-19
Queen's Medical CentreLead Sponsor
11 Previous Clinical Trials
1,631 Total Patients Enrolled
1 Trials studying COVID-19
17 Patients Enrolled for COVID-19
Todd Seto, MDPrincipal InvestigatorThe Queen's Medical Center
2 Previous Clinical Trials
37 Total Patients Enrolled
1 Trials studying COVID-19
17 Patients Enrolled for COVID-19
Frequently Asked Questions
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