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)

Sponsor
Grifols Therapeutics LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04480424
Collaborator
(none)
100
Enrollment
18
Locations
2
Arms
13.2
Actual Duration (Months)
5.6
Patients Per Site
0.4
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Biological: GAMUNEX-C
  • Drug: Standard Medical Treatment
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 17, 2020
Actual Primary Completion Date :
Aug 19, 2021
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

ArmIntervention/Treatment
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:
  • IGIV-C
  • 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

    1. All-Cause Mortality Rate Through Day 29 [Up to Day 29]

    Secondary Outcome Measures

    1. Time to Actual ICU Discharge [Day 1 through Day 29]

    2. Duration of Mechanical Ventilation [Day 1 through Day 29]

    3. Time to Actual Hospital Discharge [Day 1 through Day 29]

    4. Duration of Any Oxygen Use [Day 1 through Day 29]

    5. Mean Change from Baseline in Ordinal Scale [Day 1 through Day 29]

    6. Absolute Value Change from Baseline in Ordinal Scale [Day 1 through Day 29]

    7. Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale [Day 15, Day 29]

    8. Overall Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) [Up to Day 29]

    9. Number of Participants who Develop ARDS Distributed by Severity [Up to Day 29]

    10. Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score [Days 5, 15, and 29]

    11. Change from Baseline in National Early Warning Score (NEWS) [Day 1 through Day 29]

    12. Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [Day 1 through Day 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Chandler Regional Medical CenterChandlerArizonaUnited States85224
    2Southern California Research CenterCoronadoCaliforniaUnited States92118
    3University of Illinois at ChicagoChicagoIllinoisUnited States60612
    4Via Christi ResearchWichitaKansasUnited States67214
    5University of LouisvilleLouisvilleKentuckyUnited States40202
    6Louisiana State University Health Sciences CenterShreveportLouisianaUnited States71103
    7McLaren FlintFlintMichiganUnited States48532
    8McLaren Health Care-MacombMount ClemensMichiganUnited States48043
    9McLaren Health Care OaklandPontiacMichiganUnited States48342
    10CHI HealthOmahaNebraskaUnited States68124
    11Columbia University Medical CenterNew YorkNew YorkUnited States10032
    12Wake Forest Baptist Medical CenterWinston-SalemNorth CarolinaUnited States27517
    13Summa HealthAkronOhioUnited States44304
    14Temple University HospitalPhiladelphiaPennsylvaniaUnited States19140
    15Allegheny Health Network Research InstitutePittsburghPennsylvaniaUnited States15212
    16CHRISTUS HealthTylerTexasUnited States75701
    17MultiCare Deaconess HospitalSpokaneWashingtonUnited States99204
    18MultiCare Tacoma General HospitalTacomaWashingtonUnited States98405

    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.
    Responsible Party:
    Grifols Therapeutics LLC
    ClinicalTrials.gov Identifier:
    NCT04480424
    Other Study ID Numbers:
    • GC2007
    First Posted:
    Jul 21, 2020
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Grifols Therapeutics LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 11, 2021