COVID-19, Corona Virus Infection
Conditions
Keywords
Enzalutamide, Randomized clinical trial, COVID-19, Sars-CoV2
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.
Interventions
The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital
Sponsors
Umeå University
Sahlgrenska University Hospital
University Hospital, Umeå
Uppsala University Hospital
Skane University Hospital
Jonkoping County Hospital
Sundsvall Hospital
Helsingborgs Hospital
Göteborg University
Astellas Pharma Europe Ltd.
Norrlands University Hospital
Andreas Josefsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized (2:1), open, multicentre, clinical controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Time to improvement of disease | Up to 30 days after inclusion | Time to discharge from hospital assessed by the 7-point ordinal scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Adverse events | Up to 6 months | Safety evaluation, as measured by AEs |
| 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 |
| Laboratory assessment of liver function day 0, 2, 4 and 6 | Up to 30 days | Changes of laboratory parameters: ALAT, ASTA and/or ALP |
| Duration of supplemental oxygen (days) | Up to 30 days | Total days of extra oxygen |
Countries
Sweden
Outcome results
None listed