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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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 Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit

NCT04480424•Grifols Therapeutics LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the ICU for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission.
•Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by qualitative polymerase chain reaction (PCR) (reverse transcriptase \[RT\]-PCR), or other United States Food and Drug Administration (FDA)-approved diagnostic assay for COVID-19 in any specimen during the current hospital admission prior to randomization.
•Illness (symptoms of COVID-19 of any duration requiring ICU level care), and the following:
•1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT) scan, etc.), and
•2. Requiring mechanical ventilation and/or supplemental oxygen.
•Any one of the following related to COVID-19: i. Ferritin \> 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) \> 300 units per liter (U/L), iii. D-Dimers \> reference range, or iv. C-reactive protein (CRP) \> 40 milligram per liter (mg/L).
•Subject provides informed consent prior to initiation of any study procedures.

Exclusion Criteria

•Clinical evidence of any significant acute or chronic disease or pathophysiologic manifestations (eg, complications of COVID-19 standard medical treatments) that, in the opinion of the investigator, may place the subject at undue medical risk.
•The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or a past history of any hypersensitivity reactions to commercial immunoglobulin.
•A medical condition in which the infusion of additional fluid is contraindicated.
•Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
•Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
•Subjects with current or prior myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event (within the past 12 months) or who have a history of thromboembolic events of unknown etiology.
•Subjects with limitations of therapeutic effort.
•Female subjects who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline.
•Subjects participating in another interventional clinical trial with investigational medical product or device.
•Known history of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome.
+4 more criteria

Locations (18)

Chandler Regional Medical Center

Chandler, Arizona, United States

Southern California Research Center

Coronado, California, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Via Christi Research

Wichita, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

McLaren Flint

Flint, Michigan, United States

McLaren Health Care-Macomb

Mount Clemens, Michigan, United States

McLaren Health Care Oakland

Pontiac, Michigan, United States

CHI Health

Omaha, Nebraska, United States

Key Dates

Start Date

September 17, 2020

Primary Completion Date

August 25, 2021

Completion Date

October 25, 2021

Last Updated

October 7, 2022

Enrollment

100

ACTUAL participants

Conditions

COVID-19

Interventions

GAMUNEX-C

BIOLOGICAL

Standard Medical Treatment

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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