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

GC2007

The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.

2020-09-17

2021-08-25

2021-10-25

Completed

Early phase I

100

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2022-10-07