drugset / Trial / NCT04913779
Safety and Effectiveness of an Immunobiological Drug in CoViD-19
Phase 2/3
Unknown
200 enrolled
Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aims of this study is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbrán) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection aged 18 to 80 years.
Timeline
- Start
- 2021-06-01
- Primary completion
- 2021-11-30
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anti-SARS-CoV-2 | Protein / enzyme biologic | 10 ml | Intravenous |