Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

• Status: Completed
• Trial end date: 2021-10-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grifols Therapeutics LLC
• Treatments: Immunoglobulins, Intravenous

Criteria

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.

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.