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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412772
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Queen's Medical Centre

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Tocilizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Tocilizumab for the Treatment of Severe COVID-19
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: 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.
Drug: Tocilizumab
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.
Other Name: Actemra

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Clinical status (on a 7-point ordinal scale) at day 28 [ Time Frame: up to day 28 ]

    Clinical Status 7-point ordinal scale:

    1. Not hospitalized, no limitations on activities
    2. Not hospitalized, limitation on activities
    3. Hospitalized, not requiring supplemental oxygen
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    6. Hospitalized, on invasive mechanical ventilation or ECMO
    7. Death


Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: up to day 28 ]
    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

  2. Mechanical Ventilation [ Time Frame: up to day 28 ]
    iv. Incidence of mechanical ventilation v. Ventilator-free days

  3. Oxygenation [ Time Frame: up to day 28 ]
    vi. Duration of time on supplemental oxygen



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412772


Contacts
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Contact: Todd Seto, MD 808 354-3533 tseto@queens.org
Contact: May Vawer, RN 808 691-7185 mvawer@queens.org

Locations
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United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Todd Seto, MD    808-354-3533    tseto@queens.org   
Contact: May Vawer, RN    808 691-7185    mvawer@queens.org   
Sponsors and Collaborators
Queen's Medical Centre
Investigators
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Principal Investigator: Todd Seto, MD The Queen's Medical Center
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Responsible Party: Queen's Medical Centre
ClinicalTrials.gov Identifier: NCT04412772    
Other Study ID Numbers: RA-2020-019
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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