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 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GC2007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 18

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

Keywords

Coronavirus Disease; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2; Coronavirus Infections; Coronaviridae Infections; Virus Diseases; Immunoglobulins; Antibodies; Gamma-globulins; Immunoglobulins, Intravenous; Immunologic Factors; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality Rate Through Day 29

  All-cause mortality rate is percentage of participants in each treatment group who experienced mortality up to Day 29.

  Up to Day 29

Secondary Outcomes (12)

• Percentage of Participants With Actual Intensive Care Unit (ICU) Discharge Time

  Up to Day 29

• Duration of Mechanical Ventilation

  Up to Day 29

• Percentage of Participants With Actual Hospital Discharge Time

  Up to Day 29

• Duration of Any Oxygen Use From Day 1 Through Day 29

  Up to Day 29

• Mean Change From Baseline in Ordinal Scale

  Baseline up to Day 29

Study Arms (2)

GAMUNEX-C + Standard Medical Treatment

EXPERIMENTAL

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.

Biological: GAMUNEX-C; Drug: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

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.

Drug: Standard Medical Treatment

Interventions

GAMUNEX-C BIOLOGICAL

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

Also known as: IGIV-C

GAMUNEX-C + Standard Medical Treatment

Standard Medical Treatment DRUG

SMT per local policies or guidelines.

GAMUNEX-C + Standard Medical Treatment; Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT) scan, etc.), and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grifols Therapeutics LLC: lead

Study Sites (18)

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Via Christi Research

Wichita, Kansas, 67214, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

McLaren Flint

Flint, Michigan, 48532, United States

Location

McLaren Health Care-Macomb

Mount Clemens, Michigan, 48043, United States

Location

McLaren Health Care Oakland

Pontiac, Michigan, 48342, United States

Location

CHI Health

Omaha, Nebraska, 68124, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27517, United States

Location

Summa Health

Akron, Ohio, 44304, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

CHRISTUS Health

Tyler, Texas, 75701, United States

Location

MultiCare Deaconess Hospital

Spokane, Washington, 99204, United States

Location

MultiCare Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Coronaviridae Infections; Virus Diseases

Interventions

Hizentra

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Rhonda Griffin
• Organization: Scientific Innovation Office (SIO) Clinical Program Leader/Director Bioscience Clinical & Pharmacovigilance

Rhonda.griffin@grifols.com

+1 919 316 6693

Study Officials

• Simon Mahler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 21, 2020
• Study Start: September 17, 2020
• Primary Completion: August 25, 2021
• Study Completion: October 25, 2021
• Last Updated: October 7, 2022
• Results First Posted: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)