Created at Source Raw Value Validated value
Feb. 12, 2021, 1:30 a.m. eu

1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤ 10 days prior to the day of randomization. 2. Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to the day of randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization. 3. Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes). 4. Has mild, moderate, or severe COVID-19 5. Is willing and able to take oral medication. 6. Is male or female, ≥18 years of age, at the time of providing informed consent. 7. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: - Refrain from donating sperm PLUS either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR - Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. - Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a WOCBP OR - Is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a longterm and persistent basis), for 28 days from the start of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention - A WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Given the elevated risk of venous thrombotic events in patients hospitalized with COVID-19, estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use must adhere to Protocol. 9. Participant (or legally acceptable representative) has provided documented informed consent for the study.

1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤ 10 days prior to the day of randomization. 2. Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to the day of randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization. 3. Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes). 4. Has mild, moderate, or severe COVID-19 5. Is willing and able to take oral medication. 6. Is male or female, ≥18 years of age, at the time of providing informed consent. 7. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: - Refrain from donating sperm PLUS either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR - Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. - Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 8. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a WOCBP OR - Is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a longterm and persistent basis), for 28 days from the start of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention - A WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Given the elevated risk of venous thrombotic events in patients hospitalized with COVID-19, estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use must adhere to Protocol. 9. Participant (or legally acceptable representative) has provided documented informed consent for the study.

Dec. 15, 2020, 1:30 a.m. eu

1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤ 10 days prior to randomization. 2. Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization. 3. Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes). 4. Is willing and able to take oral medication. 5. Is male or female, ≥18 years of age, at the time of providing informed consent. 6. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: - Refrain from donating sperm PLUS either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR - Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. - Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a WOCBP OR - Is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 7 months after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. - A WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Given the elevated risk of venous thrombotic events in patients hospitalized with COVID-19, estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant’s hospitalization. If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use must adhere to Protocol. 8. Participant (or legally acceptable representative) has provided documented informed consent for the study.

1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤ 10 days prior to randomization. 2. Had initial onset of signs/symptoms attributable to COVID-19 for ≤10 days prior to randomization and ≥1 sign/symptom attributable to COVID-19 present at randomization. 3. Requires medical care in the hospital for ongoing clinical manifestations of COVID-19 (not just for public health or quarantine purposes). 4. Is willing and able to take oral medication. 5. Is male or female, ≥18 years of age, at the time of providing informed consent. 6. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: - Refrain from donating sperm PLUS either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR - Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. - Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a WOCBP OR - Is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 7 months after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. - A WOCBP must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Given the elevated risk of venous thrombotic events in patients hospitalized with COVID-19, estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant’s hospitalization. If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use must adhere to Protocol. 8. Participant (or legally acceptable representative) has provided documented informed consent for the study.