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NCT04356937 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Tocilizumab on Patients With COVID-19
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 243
- Enrollment target
NCT04356937: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT04356937 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 243 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04356937, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 243 participants
- Enrollment target
Study Summary
This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection and evidence of systemic inflammation. The aim of this study is to test the effect of Tocilizumab on multi-organ dysfunction in a phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection. Specifically, as compared to placebo, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory measures. Multi-organ dysfunction will be measured as the incidence of the following composite endpoint (mechanical ventilation, renal replacement therapy, mechanical support, need for inotropes or vasopressors, liver dysfunction (increased bilirubin), and all-cause mortality). We will also assess multiple pre-specified secondary (exploratory) endpoints and safety endpoints. We hypothesize that, as compared to placebo, tocilizumab will reduce transfer to the ICU, need for mechanical ventilation, increase rates of hospital discharge in patients diagnosed with severe COVID-19 infection and evidence of exaggerated inflammatory response.
Primary Outcome
Time from administration of the investigational agent (or placebo) to requiring mechanical ventilation and intubation, or death for subjects who die prior to intubation. The percentages of patients who have been intubated or died as of day 14 and day 28 are estimated from the Kaplan-Meier curve.
Interventions
- DRUG Placebos
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2020-04-20 |
| Est. Completion | 2020-08-27 |
| Phase | Phase 3 |
What the finished NCT04356937 record still lists
NCT04356937 is an interventional study that assigns participants to a tested intervention. The registered 243 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 (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT04356937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04356937 about?
NCT04356937 is a clinical study titled "Efficacy of Tocilizumab on Patients With COVID-19". This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection and evidence of systemic inflammation. The aim of this study is to test the effect of Tocilizumab on multi-organ ...
What is the current status of trial NCT04356937?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 243 participants. The study started on 2020-04-20. Estimated completion is 2020-08-27.
What interventions are being tested in trial NCT04356937?
The interventions under investigation include: Placebos (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT04356937?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04356937's enrollment target sits among peer trials
243 1269th of 2000 higher than 731 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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