Enzalutamide Treatment in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-05-29

Brief Summary

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COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.

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Detailed Description

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Conditions

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COVID-19 Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized (2:1), open, multicentre, clinical controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enzalutamide+Standard of Care

Up to 5 days with 4x40 mg enzalutamide tablets orally once daily

Group Type EXPERIMENTAL

Enzalutamide Pill

Intervention Type DRUG

The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital

Standard of Care

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enzalutamide Pill

The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Positive COVID-19 test
* Mild to severe symptoms of COVID-19
* Hospitalization
* WHO performance status 0-3
* Age above or equal to 50 years
* Can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
* Estimated expected survival of 1 year (excluding symptoms due to COVID-19)

Exclusion Criteria

* Severe allergy to Enzalutamide
* Pregnant or breast-feeding women
* Need of immediate mechanical ventilation
* Current medication includes enzalutamide treatment
* Stroke or Transitory Ischemic attack in medical history
* Treatment for HIV
* Treatment with tamoxifen
* Treatment with immunosuppressive agents
* Severe immunosuppressive disease
* Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)
* Previous seizure in medical history
* Other serious illness or medical condition
* Unstable cardiovascular disease

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No