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)
Study Details
Study Description
Brief Summary
The purpose of the study is to determine if a high dose of IVIG plus SMT can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: GAMUNEX-C + Standard Medical Treatment Participants will receive the first intravenous (IV) infusion of GAMUNEX-C on Day 1 up to a total net dose of 2 grams per kilogram (g/kg), based on participant's body weight (maximum dose = 160 g for participants over 80 kg), administered in divided doses as infusions of 500 milligrams per kilogram (mg/kg), based upon participant's body weight, over 4 days or 400 mg/kg, based upon participant's body weight, over 5 days. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
Biological: GAMUNEX-C
Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified
Other Names:
Drug: Standard Medical Treatment
SMT
|
Active Comparator: Standard Medical Treatment Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29. |
Drug: Standard Medical Treatment
SMT
|
Outcome Measures
Primary Outcome Measures
- All-Cause Mortality Rate Through Day 29 [Up to Day 29]
Secondary Outcome Measures
- Time to Actual ICU Discharge [Day 1 through Day 29]
- Duration of Mechanical Ventilation [Day 1 through Day 29]
- Time to Actual Hospital Discharge [Day 1 through Day 29]
- Duration of Any Oxygen Use [Day 1 through Day 29]
- Mean Change from Baseline in Ordinal Scale [Day 1 through Day 29]
- Absolute Value Change from Baseline in Ordinal Scale [Day 1 through Day 29]
- Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale [Day 15, Day 29]
- Overall Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) [Up to Day 29]
- Number of Participants who Develop ARDS Distributed by Severity [Up to Day 29]
- Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score [Days 5, 15, and 29]
- Change from Baseline in National Early Warning Score (NEWS) [Day 1 through Day 29]
- Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [Day 1 through Day 29]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Has laboratory-confirmed novel coronavirus 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.
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Illness (symptoms of COVID-19 of any duration requiring ICU level care), and the following:
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Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT) scan, etc.), and
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Requiring mechanical ventilation and/or supplemental oxygen.
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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).
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Subject provides informed consent prior to initiation of any study procedures.
Exclusion Criteria:
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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.
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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.
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A medical condition in which the infusion of additional fluid is contraindicated.
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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.
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Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
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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.
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Subjects with limitations of therapeutic effort.
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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.
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Subjects participating in another interventional clinical trial with investigational medical product or device.
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Known history of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome.
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Presence of malignancy (either new diagnosis of malignancy or known residual disease) within the past 12 months.
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Creatinine at Screening is ≥ 4 mg/dL (or subject is dependent on dialysis/renal replacement therapy).
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Known Immunoglobulin A (IgA) deficiency with anti-IgA serum antibodies.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Chandler Regional Medical Center | Chandler | Arizona | United States | 85224 |
2 | Southern California Research Center | Coronado | California | United States | 92118 |
3 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
4 | Via Christi Research | Wichita | Kansas | United States | 67214 |
5 | University of Louisville | Louisville | Kentucky | United States | 40202 |
6 | Louisiana State University Health Sciences Center | Shreveport | Louisiana | United States | 71103 |
7 | McLaren Flint | Flint | Michigan | United States | 48532 |
8 | McLaren Health Care-Macomb | Mount Clemens | Michigan | United States | 48043 |
9 | McLaren Health Care Oakland | Pontiac | Michigan | United States | 48342 |
10 | CHI Health | Omaha | Nebraska | United States | 68124 |
11 | Columbia University Medical Center | New York | New York | United States | 10032 |
12 | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | United States | 27517 |
13 | Summa Health | Akron | Ohio | United States | 44304 |
14 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
15 | Allegheny Health Network Research Institute | Pittsburgh | Pennsylvania | United States | 15212 |
16 | CHRISTUS Health | Tyler | Texas | United States | 75701 |
17 | MultiCare Deaconess Hospital | Spokane | Washington | United States | 99204 |
18 | MultiCare Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- Grifols Therapeutics LLC
Investigators
- Principal Investigator: Simon Mahler, MD, Wake Forest Baptist Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GC2007