Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)
NCT04432324 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2021-03-10
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
- BIOLOGICAL
-
Intravenous Immune Globulin
IVIG Intravenous infusion
- DRUG
-
Standard Medical Treatment
SMT
Sponsors & Collaborators
-
Instituto Grifols, S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-02
- Primary Completion
- 2021-03-03
- Completion
- 2021-03-03
Countries
- Spain
Study Locations
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