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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04509999 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
epiantadosi@ufl.edu |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-08-12 |
|
Recruitment status
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Withdrawn |
|
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 |
Blind label |
|
Center
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
unclear |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: subjects must meet all of the following criteria to be eligible for study participation: - men ≥ 36 years old diagnosed with at least one temperature elevation ≥ 100.4 f., or new cough, or new dyspnea and documented covid-19 positive by approved standard local laboratory assay - men ≥ 18 years but < 36 years old must exhibit either new cough, or new dyspnea and documented covid-19 positive by approved standard local laboratory assay. - access to working telephone or other form of communication such as email. - randomization within 7 days of covid-positive study result. all subjects will undergo repeat covid-19 assay on day 0 enrollment and a positive test is required to stay on study - written informed consent obtained from the subject and the subject agrees to comply with all study-related procedures |
|
Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
subjects with any of the following will not be eligible for study participation: - randomization greater than 7 days from a positive covid test result. all subjects will undergo repeat covid-19 assay on day 0 enrollment and a negative test will result in a screen-fail and removal from study - admission to hospital at time of screening - inclusion in another randomized trial for covid therapy - diagnosis of prostate cancer and/or treatment with anti-androgen in the past 3 months - current treatment with any androgen replacement products - prior allergic reaction or intolerance to bicalutamide or other androgen receptor inhibitors - requirement for coumarin product or warfarin products due to potential displacement by bicalutamide - subject unable to take oral bicalutamide - known hepatitis b or c - liver cirrhosis - ast/alt greater than or equal to 3 x institutional uln |
|
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 |
University of Florida |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
99 |
|
Countries
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
None |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Proportion x 100 = percent of patients with improved COVID-19 symptoms |
|
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 3 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 204, "treatment_name": "Bicalutamide", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |