A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19)
- Conditions
- Corona virus disease 2019 (COVID-19)MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002027-10-SE
- Lead Sponsor
- orrlands universitetssjukhus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
- Positive COVID-19 test
- Mild to severe symptoms of COVID-19
- Recent hospitalization due to COVID-19 (0-3 days)
- 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)
- Women of Childbearing Capacity (WOCBC) must:
a) Comply to use of highly effective contraception methods from start of the trial until three months after the last dose of study medication. Acceptable methods according to CTFG guidelines are combined hormonal contraception (oral, dermal, intravaginal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), an intrauterine device, an intrauterine hormone-releasing system or by refraining from heterosexual intercourse during the entire period of risk. Women of Childbearing Capacity (WOCBC) must:
b) Have a negative pregnancy test
- Male patients included in the study that have fertile female partners must use adequate contraception within their relationship from start of the trial until three months after the last dose of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
oSevere allergy to enzalutamide
oPregnant or Breast-feeding women
oNeed of immediate mechanical ventilation
oCurrent hormonal therapy for prostate and breast cancer (finasteride or dutasteride is allowed)
oTreatment for HIV
oTreatment with warfarin or Clopidogrel
oTreatment with immunosuppressive agents. Allowed exceptions are: equivalent medication to prednisolone 10 mg/day or low dose methotrexate 15 mg/week. Any treatment initiated as standard of care for COVID-19 is allowed.
oSevere immunosuppressive disease
oOther serious illness or medical condition
oCurrent symptomatic unstable cardiovascular disease
oStroke in medical history
oEpileptic seizure in medical history
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method