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NCT04320615 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 452
- Enrollment target
NCT04320615: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04320615 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 452 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04320615, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 452 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.
Primary Outcome
Clinical status was assessed using a 7-category ordinal scale: 1. \- Discharged (or "ready for discharge") 2. \- Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. \- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. \- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. \- ICU, requiring intubation and mechanical ventilation 6. \- ICU, requiring extracorporeal m
Interventions
- DRUG Placebo
- DRUG Tocilizumab (TCZ)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2020-04-03 |
| Est. Completion | 2020-07-28 |
| Phase | Phase 3 |
What the finished NCT04320615 record still lists
NCT04320615 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04320615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04320615 about?
NCT04320615 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia". This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.
What is the current status of trial NCT04320615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2020-04-03. Estimated completion is 2020-07-28.
What interventions are being tested in trial NCT04320615?
The interventions under investigation include: Placebo (DRUG), Tocilizumab (TCZ) (DRUG).
Who is sponsoring clinical trial NCT04320615?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04320615's enrollment target sits among peer trials
452 835th of 2000 higher than 1,165 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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