Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Enzalutamide in High Risk Male Outpatients With COVID-19
NCT04456049Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2020
- Primary completion
- Jun 2021
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- enzalutamide
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, open-label trial in coronavirus disease 2019 (COVID-19) comparing Enzalutamide + SOC with Standard of Care (2 arms). Primary endpoint: Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression at 28 days. Started Aug 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Enzalutamide + SOC
Enzalutamide 40 mg daily + Standard of Care
Standard of Care
Standard of Care alone
03
Who it enrols
Adult males aged >= 50 with mild COVID-19 and at least one high-risk factor (age >= 65, hypertension, diabetes, CVD, malignancy, COPD), excluding those requiring hospitalization or with significant cardiovascular history.
04
Endpoints
Primary
Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression
Secondary
Tolerability of Enzalutamide by identifying Adverse Events
Disease progression by unresolved SARS-CoV-2 viral expression after treatment
Beyond the preview
Go deeper on NCT04456049.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04456049.