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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-10-07

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

GAMUNEX-C

Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified.

DRUG

Standard Medical Treatment

SMT per local policies or guidelines.

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Simon Mahler, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2021-08-25
Completion
2021-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480424 on ClinicalTrials.gov