Enzalutamide Treatment in COVID-19
- Registration Number
- NCT04475601
- Lead Sponsor
- Andreas Josefsson
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 42
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enzalutamide+Standard of Care Enzalutamide Pill Up to 5 days with 4x40 mg enzalutamide tablets orally once daily
- Primary Outcome Measures
Name Time Method Time to improvement of disease Up to 30 days after inclusion Time to discharge from hospital assessed by the 7-point ordinal scale
Time to worsening of disease Up to 30 days after inclusion Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
- Secondary Outcome Measures
Name Time Method Adverse events Up to 6 months Safety evaluation, as measured by AEs
Duration of supplemental oxygen (days) Up to 30 days Total days of extra oxygen
Admission to ICU Up to 30 days and up to 6 months Frequence of admission to ICU
Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: Hb
Virus load assessment day 0, 2, 4 and 6 UP to 7 days PCR based SARS-CoV-2 measurement from upper respiratory tract
Hospital stay (days) Up to30 days and 6 months Total number of days evaluated at 30 days and 6 months
Re-admission to hospital due to rebound COVID-19 Evaluated for 30 days and after 6 months If admitted to hospital due to COVID-19 disease after discharge from hospital
Mortality at 6 months up to 30 days and up to 6 months respectively Death due to any cause
Laboratory assessment of CRP concentration day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: CRP
Laboratory assessment of liver function day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: ALAT, ASTA and/or ALP
Laboratory assessment of creatinine concentration day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: Createnin
Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: D-dimer
Laboratory assessment of platelets concentration day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: TPK
Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: IL-6
Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6 Up to 30 days Changes of laboratory parameters: Differentiate count of leucocytes
Pharmacokinetic interaction of enzalutamide with steroids Up to 30 days Maximum Plasma Concentration \[Cmax\] of steroids in blood
Trial Locations
- Locations (6)
Linköping University Hospital
🇸🇪Linköping, Sweden
Sundsvall Region Hosptial
🇸🇪Sundsvall, Sweden
Anders Bjartell
🇸🇪Malmö, Skåne, Sweden
Ryhovs Hospital
🇸🇪Jönköping, Småland, Sweden
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Umeå Univerisity Hospital
🇸🇪Umeå, Sweden