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)

NCT ID: NCT04480424

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-17
• Study Completion Date: 2021-10-25

Brief 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

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GAMUNEX-C + Standard Medical Treatment

Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.

Group Type: EXPERIMENTAL

GAMUNEX-C

Intervention Type: BIOLOGICAL

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

Standard Medical Treatment

Intervention Type: DRUG

SMT per local policies or guidelines.

Standard Medical Treatment

Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.

Group Type: ACTIVE_COMPARATOR

Standard Medical Treatment

Intervention Type: DRUG

SMT per local policies or guidelines.

Interventions

GAMUNEX-C

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

Intervention Type: BIOLOGICAL

Standard Medical Treatment

SMT per local policies or guidelines.

Intervention Type: DRUG

Other Intervention Names

IGIV-C

Eligibility Criteria

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.
• Presence of malignancy (either new diagnosis of malignancy or known residual disease) within the past 12 months.
• Creatinine at Screening is ≥ 4 mg/dL (or subject is dependent on dialysis/renal replacement therapy).
• Known Immunoglobulin A (IgA) deficiency with anti-IgA serum antibodies.
• Uncontrolled hypertension at the time of Screening (systolic blood pressure > 200 mm Hg) or refractory severe hypotension with sustained systolic blood pressure < 90 mm Hg unresponsive to vasopressors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Mahler, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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

Columbia University Medical Center

New York, New York, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Summa Health

Akron, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, United States

CHRISTUS Health

Tyler, Texas, United States

MultiCare Deaconess Hospital

Spokane, Washington, United States

MultiCare Tacoma General Hospital

Tacoma, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GC2007

Identifier Type: -

Identifier Source: org_study_id