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NCT04479358 · ClinicalTrials.gov registry record · Phase 2
Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT04479358: Clinical Trial Phase 2 study, sponsored by University of Chicago.
NCT04479358 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04479358, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation. Given limited global supplies, clarification of the optimal tocilizumab dose is critical. We conducted an open-label, randomized, controlled trial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg). Randomization was stratified on remdesivir and corticosteroid at enrollment. The primary outcome was the time to recovery. The key secondary outcome was 28-day mortality.
Primary Outcome
Day of recovery is defined as the first day on which the patient achieves one of the following two categories from a seven-point ordinal scale: 6) Hospitalized, not requiring supplemental oxygen or ongoing medical care or 7) Not hospitalized. Time to recovery is the number of days from randomization to achievement of this status. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.
Interventions
- OTHER Standard of Care
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2020-09-10 |
| Est. Completion | 2025-02-10 |
| Phase | Phase 2 |
Why NCT04479358 stopped before completion
NCT04479358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT04479358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04479358 about?
NCT04479358 is a clinical study titled "Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19". Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation. Given limited global supplies, clarification of the optimal tocilizumab dose is critical. We conducted an open-label, randomized, controlled trial evaluating two different dose le...
What is the current status of trial NCT04479358?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2020-09-10. Estimated completion is 2025-02-10.
What interventions are being tested in trial NCT04479358?
The interventions under investigation include: Standard of Care (OTHER), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT04479358?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04479358's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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