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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: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Jul 2020

At a glance

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

    • 21 Apr 2020 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.
    • 30 Mar 2020 New trial record
    • 25 Mar 2020 According to a Grifols media release, the company will is collaborating with certain hospitals in the design of this study.

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

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 [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

  • Primary Completion Dates

    Planned : 01 Dec 2020

  • End Dates

    Planned : 01 Feb 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
Elsa Mondou, MD
919-316-2079
elsa.mondou@grifols.com
show details
-
Rhonda Griffin
919-316-6693
rhonda.griffin@grifols.com
show details
-
Simon Mahler, MD
336-716-5943
show details
Wake Forest Baptist Medical Center USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Grifols Therapeutics LLC
-
-
Wake Forest Baptist Medical Center Winston-Salem, North Carolina USA

Trial History

Event Date Event Type Comment
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 2016;.

    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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