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Tocilizumab for Coronavirus (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

All Individual Drugs Already Approved

Pivotal 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

Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 28

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical status (on a 7-point ordinal scale) at day 28

Secondary study objectives

Clinical improvement

Mechanical ventilation

Oxygenation

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

agranulocytosis

Inpatient admission

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tocilizumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 1Eligibility criteria met