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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 below

ARCHITECTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 28 for reporting.

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 • NCT02034474
11%
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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS
2020. "Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04412772.
All > Covid
~62 spots leftby Apr 2025
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