drugset / Trial / NCT04432324

Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)

NCT04432324

Phase 2 Completed 100 enrolled Grifols, S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.

Timeline

Start
2020-06-02
Primary completion
2021-03-03
Completion
2021-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject intravenous immune globulin Protein / enzyme biologic 400 mg/kg Intravenous
Subject intravenous immune globulin Protein / enzyme biologic 500 mg/kg Intravenous

Indications