At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 207 enrolled
Drug / intervention
Octagam 10% +1 morebiological
Likely dose
Octagam 10% 2 gfrom 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.
Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
In Brief
A Phase 3 clinical trial evaluating Octagam 10% and Saline Solution for Covid-19. Completed, enrolled 207 participants across 22 sites in 3 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid-19
CountriesRussia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedMay 2020
Enrollment StartJun 2020
Primary CompletionFeb 2022
TodayJul 2026
First PostedMay 22, 2020
Enrollment StartJun 1, 2020
Primary CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.1 years ago
Interventions
Octagam 10%biological
Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
Saline Solutionother
Placebo