Trials / Terminated
TerminatedNCT04412772
Trial of Tocilizumab for Treatment of Severe COVID-19: ARCHITECTS
A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Tocilizumab for the Treatment of Severe COVID-19
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Queen's Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-06-12
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2020-06-02
- Last updated
- 2026-02-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04412772. Inclusion in this directory is not an endorsement.