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

Sponsor
Queen's Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04412772
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
18.6
Anticipated Duration (Months)
16.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 12, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Clinical status (on a 7-point ordinal scale) at day 28 [up to 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

    1. Clinical improvement [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 [up to day 28]

      iv. Incidence of mechanical ventilation v. Ventilator-free days

    3. Oxygenation [up to day 28]

      vi. Duration of time on supplemental oxygen

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen's Medical Center Honolulu Hawaii United States 96813

    Sponsors and Collaborators

    • Queen's Medical Center

    Investigators

    • Principal Investigator: Todd Seto, MD, The Queen's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Queen's Medical Center
    ClinicalTrials.gov Identifier:
    NCT04412772
    Other Study ID Numbers:
    • RA-2020-019
    First Posted:
    Jun 2, 2020
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Nov 17, 2020