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NCT04616586 · ClinicalTrials.gov registry record · Phase 3
SILtuximab in Viral ARds (SILVAR) Study
A Phase 3 study, sponsored by Recordati Group.
- Terminated
- Registry status
- Phase 3
- Development phase
- 555
- Enrollment target
NCT04616586: Clinical Trial Phase 3 study, sponsored by Recordati Group.
NCT04616586 is a Phase 3 study that was terminated before completion, run by Recordati Group. The registered enrollment target is 555 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616586, a Phase 3 study, was terminated before completion, sponsored by Recordati Group.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 555 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of siltuximab compared with normal saline in combination with standard of care (SOC) in selected hospitalized patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection associated with acute respiratory distress syndrome (ARDS) and elevated C-reactive protein (CRP) levels.
Primary Outcome
28-day all-cause mortality
Interventions
- DRUG Siltuximab
- OTHER Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 3 |
Why NCT04616586 stopped before completion
NCT04616586 is an interventional study that assigns participants to a tested intervention. The registered 555 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 (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Siltuximab is the first listed.
NCT04616586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04616586 about?
NCT04616586 is a clinical study titled "SILtuximab in Viral ARds (SILVAR) Study". This study will evaluate the efficacy and safety of siltuximab compared with normal saline in combination with standard of care (SOC) in selected hospitalized patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection associated with acute respiratory distr...
What is the current status of trial NCT04616586?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2020-11-13. Estimated completion is 2021-04-01.
What interventions are being tested in trial NCT04616586?
The interventions under investigation include: Siltuximab (DRUG), Normal Saline (OTHER).
Who is sponsoring clinical trial NCT04616586?
This trial is sponsored by Recordati Group, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04616586's enrollment target sits among peer trials
555 676th of 2000 higher than 1,323 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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