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

No results posted yet for this study

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

Enzalutamide

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456049 on ClinicalTrials.gov