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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432324
• Other study ID #: GC2004
• Secondary ID: 2020-001696-32
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2020
• Est. completion date: March 3, 2021

Study information

• Verified date: March 2021
• Source: Grifols Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

Biological:
• Intravenous Immune Globulin
IVIG Intravenous infusion

Drug:
• Standard Medical Treatment
SMT

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Getafe	Getafe
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Infanta Sofía	San Sebastián De Los Reyes	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Dying or Requiring ICU Admission		Up to Day 29
Primary	Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation		Day 29
Secondary	Change from Baseline in National Early Warning Score (NEWS)		Day 1 through Day 29
Secondary	Time to Clinical Response as Assessed by: NEWS = 2 Maintained for 24 hours		Day 1 through Day 29
Secondary	Time to Hospital Discharge		Day 1 through Day 29
Secondary	Duration of ICU Stay		Up to Day 29
Secondary	Duration of Any Oxygen Use		Day 1 through Day 29
Secondary	Duration of Mechanical Ventilation		Up to Day 29
Secondary	Mean Change from Baseline in Ordinal Scale		Day 1 through Day 29
Secondary	Absolute Value Change from Baseline in Ordinal Scale		Day 1 through Day 29
Secondary	Length of Time to Clinical Progression		Up to Day 29
Secondary	Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale		Day 15 and Day 29
Secondary	Time to Sustained Normalization of Temperature		Day 1 through Day 29
Secondary	Percentage of Participants with Normalization of Fever		Day 1 through Day 29
Secondary	Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS)		Day 29