Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: the subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in this protocol. understand and agree to comply with planned study procedures. male subjects with age ≥18 years of age at the time of randomization. are currently not hospitalized. have one or more mild or moderate symptom(s) covid-19-related symptoms within 5 days of onset of symptoms onset must have first positive sars-cov-2 viral infection determination (has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose. regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. use an acceptable method of contraception such as: highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to combination oral contraceptives implanted contraceptives, or intrauterine devices. effective methods of contraception comprise but are not limited to diaphragms with spermicide or cervical sponges. men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide. agree to the collection of nasopharyngeal swabs and venous blood.

inclusion criteria: the subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in this protocol. understand and agree to comply with planned study procedures. male subjects with age ≥18 years of age at the time of randomization. are currently not hospitalized. have one or more mild or moderate symptom(s) covid-19-related symptoms within 5 days of onset of symptoms onset must have first positive sars-cov-2 viral infection determination (has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose. regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. use an acceptable method of contraception such as: highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to combination oral contraceptives implanted contraceptives, or intrauterine devices. effective methods of contraception comprise but are not limited to diaphragms with spermicide or cervical sponges. men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide. agree to the collection of nasopharyngeal swabs and venous blood.

May 5, 2021, 11:25 a.m. usa

inclusion criteria: 1. the subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in this protocol. 2. understand and agree to comply with planned study procedures. 3. male subjects with age ≥18 years of age at the time of randomization. 4. are currently not hospitalized. 5. have one or more mild or moderate symptom(s) covid-19-related symptoms within 5 days of onset of symptoms onset 6. must have first positive sars-cov-2 viral infection determination (has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose. 7. regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. use an acceptable method of contraception such as: - highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to - combination oral contraceptives - implanted contraceptives, or - intrauterine devices. - effective methods of contraception comprise but are not limited to - diaphragms with spermicide or cervical sponges. - men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide. 8. agree to the collection of nasopharyngeal swabs and venous blood.

inclusion criteria: 1. the subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in this protocol. 2. understand and agree to comply with planned study procedures. 3. male subjects with age ≥18 years of age at the time of randomization. 4. are currently not hospitalized. 5. have one or more mild or moderate symptom(s) covid-19-related symptoms within 5 days of onset of symptoms onset 6. must have first positive sars-cov-2 viral infection determination (has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen) ≤3 days prior to start of the first dose. 7. regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. use an acceptable method of contraception such as: - highly effective methods of contraception (less than 1% failure rate) comprise, but are not limited to - combination oral contraceptives - implanted contraceptives, or - intrauterine devices. - effective methods of contraception comprise but are not limited to - diaphragms with spermicide or cervical sponges. - men and their partners may choose to use a double-barrier method of contraception that must include use of a spermicide. 8. agree to the collection of nasopharyngeal swabs and venous blood.