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

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Queen's Medical Center
Study ID
NCT04412772
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 12, 2020
Status verified
Feb 2026
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Queen's Medical CenterHonoluluHawaii96813-

Find similar trials in Honolulu, HI

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Queen's Medical Center· Honolulu, HI

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