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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tocilizumab
Placebo
Sponsored by
Queen's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tocilizumab (TCZ) Arm

Placebo Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Mechanical Ventilation
iv. Incidence of mechanical ventilation v. Ventilator-free days
Oxygenation
vi. Duration of time on supplemental oxygen

Full Information

First Posted
June 1, 2020
Last Updated
November 13, 2020
Sponsor
Queen's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04412772
Brief Title
Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS
Acronym
ARCHITECTS
Official Title
A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Tocilizumab for the Treatment of Severe COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab (TCZ) Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Actemra
Intervention Description
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
Primary Outcome Measure Information:
Title
Clinical status (on a 7-point ordinal scale) at day 28
Description
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
Time Frame
up to day 28
Secondary Outcome Measure Information:
Title
Clinical improvement
Description
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
Time Frame
up to day 28
Title
Mechanical Ventilation
Description
iv. Incidence of mechanical ventilation v. Ventilator-free days
Time Frame
up to day 28
Title
Oxygenation
Description
vi. Duration of time on supplemental oxygen
Time Frame
up to day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Seto, MD
Phone
808 354-3533
Email
tseto@queens.org
First Name & Middle Initial & Last Name or Official Title & Degree
May Vawer, RN
Phone
808 691-7185
Email
mvawer@queens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Seto, MD
Organizational Affiliation
The Queen's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Seto, MD
Phone
808-354-3533
Email
tseto@queens.org
First Name & Middle Initial & Last Name & Degree
May Vawer, RN
Phone
808 691-7185
Email
mvawer@queens.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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