Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)

NCT04432324 | Completed Phase 2

• 2 other identifiers: GC20042020-001696-32
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

COVID-19

Keywords

Coronavirus Disease; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Dying or Requiring ICU Admission

  Up to Day 29

• Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation

  Day 29

Secondary Outcomes (13)

• Change from Baseline in National Early Warning Score (NEWS)

  Day 1 through Day 29

• Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours

  Day 1 through Day 29

• Time to Hospital Discharge

  Day 1 through Day 29

• Duration of ICU Stay

  Up to Day 29

• Duration of Any Oxygen Use

  Day 1 through Day 29

Study Arms (2)

Intravenous Immune Globulin + Standard Medical Treatment

EXPERIMENTAL

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; Drug: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29

Drug: Standard Medical Treatment

Interventions

Intravenous Immune Globulin BIOLOGICAL

IVIG Intravenous infusion

Also known as: Flebogamma DIF

Intravenous Immune Globulin + Standard Medical Treatment

Standard Medical Treatment DRUG

SMT

Intravenous Immune Globulin + Standard Medical Treatment; Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized male or female subject ≥ 18 years of age at time of Screening who is being treated for COVID-19.
• 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.
• COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging (Chest X-Ray, Computed tomography (CT) scan, etc.).
• PaO2/FIO2 ratio \> 300 to ≤ 450 mmHg (i.e., arterial oxygen in mmHg divided by fraction inspired oxygen concentration \[e.g., 0.21 for room air\])
• 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 (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.

You may not qualify if:

• Subject requires invasive mechanical ventilation or ICU admission.
• Clinical evidence of any significant acute or chronic disease 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 commercial immunoglobulin.
• Subject has known (documented) hereditary fructose intolerance (HFI).
• 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.
• Subject with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
• Subject with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event.
• Subject with limitations of therapeutic effort (eg, 'do not resuscitate' status).
• 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.
• Subject participating in another interventional clinical trial with investigational medical product or device.

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (10)

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, CP 08041, Spain

Location

Hospital Universitario de Getafe

Getafe, 28905, Spain

Location

Hospital Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: June 2, 2020
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)