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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 04 May 2021

At a glance

  • Drugs Immune globulin (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Sponsors Grifols
  • Most Recent Events

    • 30 Apr 2021 Planned End Date changed from 1 May 2021 to 1 Oct 2021.
    • 30 Apr 2021 Planned primary completion date changed from 1 Apr 2021 to 1 Jul 2021.
    • 12 Nov 2020 Planned End Date changed from 1 Feb 2021 to 1 May 2021.

Trial Overview

Purpose

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.

Primary Endpoints

All-Cause Mortality Rate Through Day 29

time_frame: Up to Day 29

Other Endpoints

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 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 100

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04480424 ClinicalTrials.gov: US National Institutes of Health
GC2007 -

Organisations

  • Sponsors Grifols
  • Affiliations Grifols

Trial Dates

  • Initiation Dates

    Planned : 01 Jul 2020

    Actual : 17 Sep 2020

  • Primary Completion Dates

    Planned : 01 Jul 2021

  • End Dates

    Planned : 01 Oct 2021

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
Immune globulinPrimary Drug Intravenous Infusion

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)

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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Christopher Provenzano, MD McLaren Health Care-Macomb USA
Daniel Coulston, MD MultiCare Deaconess Hospital USA
Elsa Mondou, MD
919-316-2079 elsa.mondou@grifols.com
show details
-
Franklin Rosenblat, MD McLaren Health Care Oakland USA
John Youssef, MD McLaren Flint USA
Kristopher Roach, MD Chandler Regional Medical Center USA
Leon Tung, MD CHRISTUS Health USA
Margaret Hagan, MD Via Christi Research USA
Michael Tan, MD Summa Health USA
Mohamed Saad, MD University of Louisville USA
Monica Goldklang, MD Columbia University Medical Center USA
Rhonda Griffin
919-316-6693 rhonda.griffin@grifols.com
show details
-
Robert Plambeck, MD CHI Health USA
Scott Meehan, MD MultiCare Tacoma General Hospital USA
Simon Mahler, MD Wake Forest Baptist Medical Center USA
Steven Conrad, MD Louisiana State University Health Sciences Center USA
Tariq Cheema, MD Allegheny Health Network Research Institute USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Allegheny Health Network Research Institute Pittsburgh, Pennsylvania USA
Chandler Regional Medical Center Chandler, Arizona USA
CHI Health Omaha, Nebraska USA
CHRISTUS Health Tyler, Texas USA
Columbia University Medical Center New York, New York USA
Grifols Therapeutics LLC
-
-
Louisiana State University Health Sciences Center Shreveport, Louisiana USA
McLaren Flint Flint, Michigan USA
McLaren Health Care Oakland Pontiac, Michigan USA
McLaren Health Care-Macomb Mount Clemens, Michigan USA
MultiCare Deaconess Hospital Spokane, Washington USA
MultiCare Tacoma General Hospital Tacoma, Washington USA
Summa Health Akron, Ohio USA
University of Louisville Louisville, Kentucky USA
Via Christi Research Wichita, Kansas USA
Wake Forest Baptist Medical Center Winston-Salem, North Carolina USA

Trial History

Event Date Event Type Comment
04 May 2021 Other trial event Last checked against Clinicaltrials.gov record. Updated 04 May 2021
30 Apr 2021 Completion date Planned End Date changed from 1 May 2021 to 1 Oct 2021. Updated 04 May 2021
30 Apr 2021 Other trial event Planned primary completion date changed from 1 Apr 2021 to 1 Jul 2021. Updated 04 May 2021
12 Nov 2020 Completion date Planned End Date changed from 1 Feb 2021 to 1 May 2021. Updated 18 Nov 2020
12 Nov 2020 Other trial event Planned primary completion date changed from 1 Dec 2020 to 1 Apr 2021. Updated 18 Nov 2020
21 Sep 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 24 Sep 2020
23 Jul 2020 Other trial event New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health: NCT04480424). Updated 23 Jul 2020
21 Apr 2020 Other trial event According to a Grifols media release, the company is leading this trial in collaboration with the U.S. Food and Drug Administration (FDA) and other health agencies. Updated 22 Apr 2020
30 Mar 2020 New trial record New trial record Updated 30 Mar 2020
25 Mar 2020 Other trial event According to a Grifols media release, the company will is collaborating with certain hospitals in the design of this study. Updated 30 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Grifols. Grifols Announces Formal Collaboration with US Government to Produce the First Treatment Specifically Targeting COVID-19. Media-Rel 2020;.

    Media Release
  3. Grifols. Grifols maintains its operational levels and continues to reinforce its commitment to society. Media-Rel 2020;.

    Media Release
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