Clinical trial NCT04475601: Enzalutamide Treatment in COVID-19
Official title: A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Corona Virus Infection
Keywords: Enzalutamide
Randomized clinical trial
COVID-19
Sars-CoV2
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
name: Sahlgrenska University Hospital
name: University Hospital, Umeå
name: Uppsala University Hospital
name: Skane University Hospital
name: Jonkoping County Hospital
name: Sundsvall Hospital
name: Helsingborgs Hospital
name: Göteborg University
name: Astellas Pharma Europe Ltd.
name: Norrlands University Hospital
First posted: 2020-07-17
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized (2:1), open, multicentre, clinical controlled trial
Primary purpose: TREATMENT

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.


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)
* Previous seizure in medical history
* Other serious illness or medical condition
* Unstable cardiovascular disease

Primary outcomes:
measure: Time to worsening of disease
timeFrame: Up to 30 days after inclusion
measure: Time to improvement of disease
timeFrame: Up to 30 days after inclusion
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 6 months
measure: Duration of supplemental oxygen (days)
timeFrame: Up to 30 days
measure: Admission to ICU
timeFrame: Up to 30 days and up to 6 months
measure: Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Virus load assessment day 0, 2, 4 and 6
timeFrame: UP to 7 days
measure: Hospital stay (days)
timeFrame: Up to30 days and 6 months
measure: Re-admission to hospital due to rebound COVID-19
timeFrame: Evaluated for 30 days and after 6 months
measure: Mortality at 6 months
timeFrame: up to 30 days and up to 6 months respectively
measure: Laboratory assessment of CRP concentration day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Laboratory assessment of liver function day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Laboratory assessment of creatinine concentration day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Laboratory assessment of platelets concentration day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6
timeFrame: Up to 30 days
measure: Pharmacokinetic interaction of enzalutamide with steroids
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Anders Bjartell
state: Skåne
city: Jönköping
country: Sweden
facility: Ryhovs Hospital
state: Småland
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall Region Hosptial
city: Umeå
country: Sweden
facility: Umeå Univerisity Hospital
Study officials:
affiliation: Norrlands University Hospital, Region Västerbotten
name: Andreas Josefsson, MdPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welen K, Overby AK, Ahlm C, Freyhult E, Robinsson D, Henningsson AJ, Stranne J, Bremell D, Angelin M, Lindquist E, Buckland R, Carlsson CT, Pauksens K, Bill-Axelsson A, Akre O, Ryden C, Wagenius M, Bjartell A, Nilsson AC, Styrke J, Repo J, Balkhed AO, Niward K, Gisslen M, Josefsson A. COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Mar 16;22(1):209. doi: 10.1186/s13063-021-05137-4.