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By sponsor, based on DSMB recommendations
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| Name | Class |
|---|---|
| Umeå University | OTHER |
| Sahlgrenska University Hospital | OTHER |
| University Hospital, Umeå | OTHER |
| Uppsala University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide+Standard of Care | Experimental | Up to 5 days with 4x40 mg enzalutamide tablets orally once daily |
|
| Standard of Care | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide Pill | Drug | The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to worsening of disease | Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale | Up to 30 days after inclusion |
| Time to improvement of disease | Time to discharge from hospital assessed by the 7-point ordinal scale | Up to 30 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Safety evaluation, as measured by AEs | Up to 6 months |
| Duration of supplemental oxygen (days) | Total days of extra oxygen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Josefsson, MdPhD | Norrlands University Hospital, Region Västerbotten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anders Bjartell | Malmö | Skåne County | Sweden | |||
| Ryhovs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33726804 | Derived | 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. |
| Label | URL |
|---|---|
| Publication of the results | View source |
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The extent of sharing will be regulated during the trial to consider the integrity of the data according GDPR and national laws
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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| OTHER |
| Skane University Hospital | OTHER |
| Jonkoping County Hospital | OTHER |
| Sundsvall Hospital | OTHER |
| Helsingborgs Hospital | OTHER |
| Göteborg University | OTHER |
| Astellas Pharma Europe Ltd. | INDUSTRY |
| Norrlands University Hospital | OTHER |
Prospective, randomized (2:1), open, multicentre, clinical controlled trial
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| Up to 30 days |
| Admission to ICU | Frequence of admission to ICU | Up to 30 days and up to 6 months |
| Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6 | Changes of laboratory parameters: Hb | Up to 30 days |
| Virus load assessment day 0, 2, 4 and 6 | PCR based SARS-CoV-2 measurement from upper respiratory tract | UP to 7 days |
| Hospital stay (days) | Total number of days evaluated at 30 days and 6 months | Up to30 days and 6 months |
| Re-admission to hospital due to rebound COVID-19 | If admitted to hospital due to COVID-19 disease after discharge from hospital | Evaluated for 30 days and after 6 months |
| Mortality at 6 months | Death due to any cause | up to 30 days and up to 6 months respectively |
| Laboratory assessment of CRP concentration day 0, 2, 4 and 6 | Changes of laboratory parameters: CRP | Up to 30 days |
| Laboratory assessment of liver function day 0, 2, 4 and 6 | Changes of laboratory parameters: ALAT, ASTA and/or ALP | Up to 30 days |
| Laboratory assessment of creatinine concentration day 0, 2, 4 and 6 | Changes of laboratory parameters: Createnin | Up to 30 days |
| Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6 | Changes of laboratory parameters: D-dimer | Up to 30 days |
| Laboratory assessment of platelets concentration day 0, 2, 4 and 6 | Changes of laboratory parameters: TPK | Up to 30 days |
| Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6 | Changes of laboratory parameters: IL-6 | Up to 30 days |
| Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6 | Changes of laboratory parameters: Differentiate count of leucocytes | Up to 30 days |
| Pharmacokinetic interaction of enzalutamide with steroids | Maximum Plasma Concentration [Cmax] of steroids in blood | Up to 30 days |
| Jönköping |
| Småland |
| Sweden |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Linköping University Hospital | Linköping | Sweden |
| Sundsvall Region Hosptial | Sundsvall | Sweden |
| Umeå Univerisity Hospital | Umeå | Sweden |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |