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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.

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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

FieldValue
Enrollment Target 100 participants
Start Date 2020-09-17
Est. Completion 2021-10-25
Phase Phase 2

Sponsor

Grifols Therapeutics

34 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.