At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
GAMUNEX-C +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GAMUNEX-C and Standard Medical Treatment for COVID-19. Completed, enrolled 100 participants across 18 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartSep 2020
Primary CompletionAug 2021
Study CompletionOct 2021
TodayJul 2026
First PostedJul 21, 2020
Enrollment StartSep 17, 2020
Primary CompletionAug 25, 2021
Study CompletionOct 25, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.9 years ago
Interventions
GAMUNEX-Cbiological
Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified.
Standard Medical Treatmentdrug
SMT per local policies or guidelines.