Created at Source Raw Value Validated value
June 25, 2024, noon usa

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

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

Jan. 29, 2021, 12:31 a.m. usa

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

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

Oct. 27, 2020, 11:31 p.m. usa

subjects with any of the following will not be eligible for study participation: - 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

subjects with any of the following will not be eligible for study participation: - 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

Oct. 26, 2020, 11:31 p.m. usa

subjects with any of the following will not be eligible for study participation: - a. randomization > 48 hours of a positive covid test result - b. admission to hospital at time of screening - c. inclusion in another randomized trial for covid therapy - d. diagnosis of prostate cancer and/or treatment with anti-androgen in the past 3 months (see appendix for list of drugs with anti-androgen activity). - e. current treatment with any androgen replacement products - f. prior allergic reaction or intolerance to bicalutamide or other androgen receptor inhibitors - g. requirement for coumarin product or warfarin products due to potential displacement by bicalutamide - h. subject unable to take oral bicalutamide - i. known hepatitis b or c - j. liver cirrhosis - k. ast/alt greater than or equal to 3 x institutional uln

subjects with any of the following will not be eligible for study participation: - a. randomization > 48 hours of a positive covid test result - b. admission to hospital at time of screening - c. inclusion in another randomized trial for covid therapy - d. diagnosis of prostate cancer and/or treatment with anti-androgen in the past 3 months (see appendix for list of drugs with anti-androgen activity). - e. current treatment with any androgen replacement products - f. prior allergic reaction or intolerance to bicalutamide or other androgen receptor inhibitors - g. requirement for coumarin product or warfarin products due to potential displacement by bicalutamide - h. subject unable to take oral bicalutamide - i. known hepatitis b or c - j. liver cirrhosis - k. ast/alt greater than or equal to 3 x institutional uln