Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04456049
Status:
TERMINATED
Last Update Posted:
2022-08-10
First Post:
2020-07-01
Brief Title:
Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
Sponsor:
Ricardo Pereira Mestre
Organization:
Ente Ospedaliero Cantonale Bellinzona
Study Overview
Official Title:
COVID_ENZA Trial Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 po 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
Patients will be randomized to receive Enzalutamide with standard of care SOC or SOC alone Enzalutamide will be administered daily po 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None