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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)

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ClinicalTrials.gov Identifier: NCT04480424
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Tracking Information
First Submitted Date  ICMJE July 20, 2020
First Posted Date  ICMJE July 21, 2020
Last Update Posted Date November 24, 2020
Actual Study Start Date  ICMJE September 17, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
All-Cause Mortality Rate Through Day 29 [ Time Frame: Up to Day 29 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • Time to Actual ICU Discharge [ Time Frame: Day 1 through Day 29 ]
  • Duration of Mechanical Ventilation [ Time Frame: Day 1 through Day 29 ]
  • Time to Actual Hospital Discharge [ Time Frame: Day 1 through Day 29 ]
  • Duration of Any Oxygen Use [ Time Frame: Day 1 through Day 29 ]
  • Mean Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  • Absolute Value Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  • Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale [ Time Frame: Day 15, Day 29 ]
  • Overall Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Up to Day 29 ]
  • Number of Participants who Develop ARDS Distributed by Severity [ Time Frame: Up to Day 29 ]
  • Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Days 5, 15, and 29 ]
  • Change from Baseline in National Early Warning Score (NEWS) [ Time Frame: Day 1 through Day 29 ]
  • Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
  • Time to Actual ICU Discharge [ Time Frame: Day 1 through Day 29 ]
  • Duration of Mechanical Ventilation [ Time Frame: Day 1 through Day 29 ]
  • Time to Actual Hospital Discharge [ Time Frame: Day 1 through Day 29 ]
  • Duration of Any Oxygen Use [ Time Frame: Day 1 through Day 29 ]
  • Absolute Value and Mean Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  • Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale [ Time Frame: Day 15, Day 29 ]
  • Overall Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Up to Day 29 ]
  • Number of Participants who Develop ARDS Distributed by Severity [ Time Frame: Up to Day 29 ]
  • Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Days 5, 15, and 29 ]
  • Change from Baseline in National Early Warning Score (NEWS) [ Time Frame: Day 1 through Day 29 ]
  • Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: GAMUNEX-C
    Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified
    Other Name: IGIV-C
  • Drug: Standard Medical Treatment
    SMT
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: GAMUNEX-C
    • Drug: Standard Medical Treatment
  • 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.
    Intervention: Drug: Standard Medical Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rhonda Griffin 919-316-6693 rhonda.griffin@grifols.com
Contact: Elsa Mondou, MD 919-316-2079 elsa.mondou@grifols.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04480424
Other Study ID Numbers  ICMJE GC2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Grifols Therapeutics LLC
Study Sponsor  ICMJE Grifols Therapeutics LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon Mahler, MD Wake Forest Baptist Medical Center
PRS Account Grifols Therapeutics LLC
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP