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NCT04480424 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
A Phase 2 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT04480424: Completed Phase 2 study, sponsored by Grifols Therapeutics.
NCT04480424 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04480424, a Phase 2 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
Primary Outcome
All-cause mortality rate is percentage of participants in each treatment group who experienced mortality up to Day 29.
Interventions
- BIOLOGICAL GAMUNEX-C
- DRUG Standard Medical Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2021-10-25 |
| Phase | Phase 2 |
What the finished NCT04480424 record still lists
NCT04480424 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which GAMUNEX-C is the first listed.
NCT04480424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04480424 about?
NCT04480424 is a clinical study titled "Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)". The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
What is the current status of trial NCT04480424?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2020-09-17. Estimated completion is 2021-10-25.
What interventions are being tested in trial NCT04480424?
The interventions under investigation include: GAMUNEX-C (BIOLOGICAL), Standard Medical Treatment (DRUG).
Who is sponsoring clinical trial NCT04480424?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04480424's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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