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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480424
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

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
COVID-19 Biological: GAMUNEX-C Drug: Standard Medical Treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 17, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/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 Name: 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




Primary Outcome Measures :
  1. All-Cause Mortality Rate Through Day 29 [ Time Frame: Up to Day 29 ]

Secondary Outcome Measures :
  1. Time to Actual ICU Discharge [ Time Frame: Day 1 through Day 29 ]
  2. Duration of Mechanical Ventilation [ Time Frame: Day 1 through Day 29 ]
  3. Time to Actual Hospital Discharge [ Time Frame: Day 1 through Day 29 ]
  4. Duration of Any Oxygen Use [ Time Frame: Day 1 through Day 29 ]
  5. Mean Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  6. Absolute Value Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  7. Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale [ Time Frame: Day 15, Day 29 ]
  8. Overall Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Up to Day 29 ]
  9. Number of Participants who Develop ARDS Distributed by Severity [ Time Frame: Up to Day 29 ]
  10. Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Days 5, 15, and 29 ]
  11. Change from Baseline in National Early Warning Score (NEWS) [ Time Frame: Day 1 through Day 29 ]
  12. Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480424


Contacts
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Contact: Rhonda Griffin 919-316-6693 rhonda.griffin@grifols.com
Contact: Elsa Mondou, MD 919-316-2079 elsa.mondou@grifols.com

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mohamed Saad, MD         
United States, Michigan
McLaren Flint Recruiting
Flint, Michigan, United States, 48532
Contact: John Youssef, MD         
McLaren Health Care Oakland Recruiting
Pontiac, Michigan, United States, 48342
Contact: Franklin Rosenblat, MD         
United States, Nebraska
CHI Health Recruiting
Omaha, Nebraska, United States, 68124
Contact: Robert Plambeck, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Monica Goldklang, MD         
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27517
Contact: Simon Mahler, MD         
United States, Washington
MultiCare Deaconness Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Daniel Coulston, MD         
MultiCare Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Scott Meehan, MD         
Sponsors and Collaborators
Grifols Therapeutics LLC
Investigators
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Principal Investigator: Simon Mahler, MD Wake Forest Baptist Medical Center
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Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT04480424    
Other Study ID Numbers: GC2007
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Grifols Therapeutics LLC:
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
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs