Enzalutamide Treatment in COVID-19 (COVIDENZA)

Andreas Josefsson

Status and phase: Terminated; Phase 2

Conditions: COVID-19; Corona Virus Infection

Treatments: Drug: Enzalutamide Pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04475601

COVIDENZA

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Enzalutamide+Standard of Care

Experimental group

Description:

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

Treatment:

Drug: Enzalutamide Pill

Standard of Care

No Intervention group

Description:

Standard of care