Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
NCT04456049 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2022-08-10
Summary
High risk outpatient adult males with a confirmed SARS-CoV-2 infection will be included in the study.
Patients will be randomized to receive Enzalutamide with standard of care (SOC) or SOC alone. Enzalutamide will be administered daily p.o. from Day 1 to Day 28 or until confirmed negativization of Nasopharyngeal swap (NPS) Polymerase chain reaction (PCR) (2 consecutive negative samples), whichever occurs first.
Conditions
- COVID-19 Infection
Interventions
- DRUG
-
40 mg oral tablets once daily for a maximum of 28 days.
Sponsors & Collaborators
-
Oncology Institute of Southern Switzerland
collaborator OTHER -
Institute of Oncology Research
collaborator UNKNOWN -
Institute for Research in Biomedicine
collaborator UNKNOWN -
Ricardo Pereira Mestre
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-24
- Primary Completion
- 2021-06-09
- Completion
- 2021-06-09
Countries
- Switzerland
Study Locations
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