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Trial - NCT04475601


Column Value
Trial registration number NCT04475601
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04475601

First author
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Andreas Josefsson, MDPhD

Contact
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

andreas.josefsson@umu.se

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-17

Recruitment status
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Andreas Josefsson

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

50

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Sweden

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

42

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Time to improvement of disease;Time to worsening of disease

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 468, "treatment_name": "Enzalutamide", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]