Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Immune Globulin · 2 trials · 2 indications
Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 |
| Immune Globulin Intravenous (Human) | EXPERIMENTAL | Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified |
| Name | Type | Description |
|---|---|---|
| Intravenous Immune Globulin | BIOLOGICAL | IVIG Intravenous infusion |
| Standard Medical Treatment | DRUG | SMT |
| Immune Globulin Intravenous (Human) | BIOLOGICAL | This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months. |
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), ...
Immune Globulin is an investigational monoclonal antibody being studied for COVID-19 and Immunologic Deficiency Syndrome. It is developed by Grifols, S.A. and is currently in Phase 2 clinical development for these indications.
Immune Globulin is developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker GRFS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Immune Globulin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its safety and efficacy for COVID-19 and Immunologic Deficiency Syndrome.
Immune Globulin has been studied in two Phase 2 trials. NCT00389324 evaluated subcutaneous Gamunex in primary immunodeficiency with 35 participants in the United States and Canada. NCT04432324 studied high dose IVIG in hospitalized COVID-19 patients with 100 participants in Spain.
Immune Globulin is also known as Gamunex, as indicated by the clinical trial NCT00389324, which evaluated subcutaneous Gamunex in primary immunodeficiency. This alternative name may be used in some contexts to refer to the same drug product.