Trials / Completed
CompletedNCT04432324
Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants 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 Hospitalized Subjects With COVID-19
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Instituto Grifols, S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Intravenous Immune Globulin | IVIG Intravenous infusion |
| DRUG | Standard Medical Treatment | SMT |
Timeline
- Start date
- 2020-06-02
- Primary completion
- 2021-03-03
- Completion
- 2021-03-03
- First posted
- 2020-06-16
- Last updated
- 2021-03-10
Locations
10 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04432324. Inclusion in this directory is not an endorsement.