Trials / Completed
CompletedNCT04480424
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)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Grifols Therapeutics LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GAMUNEX-C | Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified. |
| DRUG | Standard Medical Treatment | SMT per local policies or guidelines. |
Timeline
- Start date
- 2020-09-17
- Primary completion
- 2021-08-25
- Completion
- 2021-10-25
- First posted
- 2020-07-21
- Last updated
- 2022-10-07
- Results posted
- 2022-10-07
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04480424. Inclusion in this directory is not an endorsement.