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

NCT ID: NCT04412772

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-12

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tocilizumab (TCZ) Arm

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 Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.

Placebo Arm

Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Tocilizumab

Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Actemra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Seto, MD

Role: PRINCIPAL_INVESTIGATOR

The Queen's Medical Center

Locations

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Queen's Medical Center

Honolulu, Hawaii, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Todd Seto, MD

Role: CONTACT

Phone: 808 354-3533

Email: [email protected]

May Vawer, RN

Role: CONTACT

Phone: 808 691-7185

Email: [email protected]

Facility Contacts

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Todd Seto, MD

Role: primary

May Vawer, RN

Role: backup

Other Identifiers

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RA-2020-019

Identifier Type: -

Identifier Source: org_study_id