Enzalutamide Treatment in COVID-19

Phase 2TerminatedNCT04475601

Andreas Josefsson42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Corona Virus Infection

Interventions

Enzalutamide PillDRUG

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (6)

Anders Bjartell

Malmo, Skåne County, Sweden

Ryhovs Hospital

Jönköping, Småland, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Linköping University Hospital

Linköping, Sweden

Outcomes

Primary Outcomes

Time to worsening of disease

Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale

Time frame: Up to 30 days after inclusion

Time to improvement of disease

Time to discharge from hospital assessed by the 7-point ordinal scale

Time frame: Up to 30 days after inclusion

Secondary Outcomes

Adverse events

Safety evaluation, as measured by AEs

Time frame: Up to 6 months

Duration of supplemental oxygen (days)

Total days of extra oxygen

Time frame: Up to 30 days

Admission to ICU

Frequence of admission to ICU

Time frame: Up to 30 days and up to 6 months

Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6

Changes of laboratory parameters: Hb

Time frame: Up to 30 days

Virus load assessment day 0, 2, 4 and 6

PCR based SARS-CoV-2 measurement from upper respiratory tract

Time frame: UP to 7 days

Hospital stay (days)

Total number of days evaluated at 30 days and 6 months

Time frame: Up to30 days and 6 months

Re-admission to hospital due to rebound COVID-19

Data from ClinicalTrials.gov

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