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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 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 100 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04480424
The ClinicalTrials.gov registry entry for NCT04480424 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GAMUNEX-C is the first listed.
NCT04480424 reports 0 study locations.
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.
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