A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)
Overview
- Phase
- Phase 2
- Intervention
- Enzalutamide Pill
- Conditions
- COVID-19
- Sponsor
- Andreas Josefsson
- Enrollment
- 42
- Locations
- 6
- Primary Endpoint
- Time to improvement of disease
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Andreas Josefsson
Assistant Professor and Consultant Urologist
Region Västerbotten
Eligibility Criteria
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)
Arms & Interventions
Enzalutamide+Standard of Care
Up to 5 days with 4x40 mg enzalutamide tablets orally once daily
Intervention: Enzalutamide Pill
Outcomes
Primary Outcomes
Time to improvement of disease
Time Frame: Up to 30 days after inclusion
Time to discharge from hospital assessed by the 7-point ordinal scale
Time to worsening of disease
Time Frame: Up to 30 days after inclusion
Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
Secondary Outcomes
- Adverse events(Up to 6 months)
- Duration of supplemental oxygen (days)(Up to 30 days)
- Admission to ICU(Up to 30 days and up to 6 months)
- Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6(Up to 30 days)
- Virus load assessment day 0, 2, 4 and 6(UP to 7 days)
- Hospital stay (days)(Up to30 days and 6 months)
- Re-admission to hospital due to rebound COVID-19(Evaluated for 30 days and after 6 months)
- Mortality at 6 months(up to 30 days and up to 6 months respectively)
- Laboratory assessment of CRP concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of liver function day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of creatinine concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of platelets concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6(Up to 30 days)
- Pharmacokinetic interaction of enzalutamide with steroids(Up to 30 days)