drugset / Trial / NCT04480424

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)

NCT04480424

Phase 2 Completed 100 enrolled Grifols Therapeutics LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-17
Primary completion
2021-08-25
Completion
2021-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous

Indications