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Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants 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: NCT04432324
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC ( Instituto Grifols, S.A. )

Brief Summary:
The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Intravenous Immune Globulin 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 Hospitalized Subjects With COVID-19
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous Immune Globulin + Standard Medical Treatment
Participants will receive the first intravenous (IV) infusion of IVIG on Day 1 up to a net dose of 2 gram per kilogram (g/kg), based upon participant's (body weight) administered in divided doses as infusions of 500 milligram 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: Intravenous Immune Globulin
IVIG Intravenous infusion
Other Name: Flebogamma DIF

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. Percentage of Participants Dying or Requiring ICU Admission [ Time Frame: Up to Day 29 ]
  2. Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation [ Time Frame: Day 29 ]

Secondary Outcome Measures :
  1. Change from Baseline in National Early Warning Score (NEWS) [ Time Frame: Day 1 through Day 29 ]
  2. Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
  3. Time to Hospital Discharge [ Time Frame: Day 1 through Day 29 ]
  4. Duration of ICU Stay [ Time Frame: Up to Day 29 ]
  5. Duration of Any Oxygen Use [ Time Frame: Day 1 through Day 29 ]
  6. Duration of Mechanical Ventilation [ Time Frame: Up to Day 29 ]
  7. Mean Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  8. Absolute Value Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  9. Length of Time to Clinical Progression [ Time Frame: Up to Day 29 ]
  10. Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale [ Time Frame: Day 15 and Day 29 ]
  11. Time to Sustained Normalization of Temperature [ Time Frame: Day 1 through Day 29 ]
  12. Percentage of Participants with Normalization of Fever [ Time Frame: Day 1 through Day 29 ]
  13. Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 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:

  1. Hospitalized male or female subject ≥ 18 years of age at time of Screening who is being treated for COVID-19.
  2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR), or other commercial or public health assay (of any type) in any specimen during the current hospital admission prior to randomization.
  3. COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging (Chest X-Ray, Computed tomography (CT) scan, etc.).
  4. PaO2/FIO2 ratio > 300 to ≤ 450 mmHg (i.e., arterial oxygen in mmHg divided by fraction inspired oxygen concentration [e.g., 0.21 for room air])
  5. 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).
  6. Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides oral informed consent prior to initiation of any study procedures.

Exclusion criteria:

  1. Subject requires invasive mechanical ventilation or ICU admission.
  2. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator may place the subject at undue medical risk.
  3. The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin.
  4. Subject has known (documented) hereditary fructose intolerance (HFI).
  5. A medical condition in which the infusion of additional fluid is contraindicated.
  6. 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.
  7. Subject with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
  8. Subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event.
  9. Subject with limitations of therapeutic effort (eg, 'do not resuscitate' status).
  10. Female subject 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.
  11. Subject participating in another interventional clinical trial with investigational medical product or device.

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): NCT04432324


Contacts
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Contact: Navarro Puerto Jordi +34935712200 jordi.navarro@grifols.com
Contact: Elsa Mondou 919-316-2079 elsa.mondou@grifols.com

Locations
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Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Spain, 08916
Contact: Maria Lluisa Pedro-Botet, MD         
Principal Investigator: Maria Lluisa Pedro-Botet, MD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Benito Almirante Gragera, MD         
Principal Investigator: Benito Almirante Gragera, MD         
Hospital Universitari de Bellvitge Recruiting
Barcelona, Spain, 08907
Contact: Xavier Solanich Moreno, MD         
Principal Investigator: Xavier Solanich Moreno, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, CP 08041
Contact: Pere Domingo Pedrol, MD         
Principal Investigator: Pere Domingo Pedrol, MD         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Javier Alberto Carbone Campoverde, MD         
Principal Investigator: Javier Alberto Carbone Campoverde, MD         
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Vicente Estrada Perez, MD         
Principal Investigator: Vicente Estrada Perez, MD         
Sponsors and Collaborators
Instituto Grifols, S.A.
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Responsible Party: Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT04432324    
Other Study ID Numbers: GC2004
2020-001696-32 ( EudraCT Number )
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Grifols Therapeutics LLC ( Instituto Grifols, S.A. ):
Coronavirus Disease
Severe acute respiratory syndrome coronavirus 2
SARS-CoV-2
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs