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

NCT04412772 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tocilizumab

Participants will receive 1 dose of IV TCZ. 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.

Sponsors & Collaborators

  • Queen's Medical Center

    lead OTHER

Principal Investigators

  • Todd Seto, MD · The Queen's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04412772 on ClinicalTrials.gov