Trials / Completed
CompletedNCT04495101
Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19
A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Prolastin 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 primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Prolastin | Intravenous infusion 120 mg/kg |
| DRUG | Standard Medical Treatment | Standard medical treatment per local policies or guidelines |
Timeline
- Start date
- 2020-07-29
- Primary completion
- 2021-04-26
- Completion
- 2021-06-10
- First posted
- 2020-07-31
- Last updated
- 2021-07-08
Locations
9 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04495101. Inclusion in this directory is not an endorsement.