Created at Source Raw Value Validated value
April 23, 2021, 1:30 a.m. eu

1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤7 days prior to randomization. 2. Has initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization: -Cough -Sore throat -Nasal congestion -Runny nose -Shortness of breath or difficulty breathing -Muscle or body aches -Fatigue -Fever 38.0◦C -Chills -Headache -Nausea -Vomiting -Diarrhea -Loss of smell -Loss of taste 3. Has mild or moderate COVID-19, participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. 4. Has oxygenation saturation of >93% (on room air OR on supplemental oxygen prior to randomization which has not increased since onset of COVID-19 signs/symptoms) obtained at rest by study staff at randomization. 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 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 (urine or serum as required by local regulations) 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. 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 the 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 ≤7 days prior to randomization. 2. Has initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization: -Cough -Sore throat -Nasal congestion -Runny nose -Shortness of breath or difficulty breathing -Muscle or body aches -Fatigue -Fever 38.0◦C -Chills -Headache -Nausea -Vomiting -Diarrhea -Loss of smell -Loss of taste 3. Has mild or moderate COVID-19, participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. 4. Has oxygenation saturation of >93% (on room air OR on supplemental oxygen prior to randomization which has not increased since onset of COVID-19 signs/symptoms) obtained at rest by study staff at randomization. 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 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 (urine or serum as required by local regulations) 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. 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 the Protocol. 9. Participant (or legally acceptable representative) has provided documented informed consent for the study.

Feb. 12, 2021, 1:30 a.m. eu

1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤7 days prior to the day of randomization. 2. Had initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to the day of randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization: -Cough -Sore throat -Nasal congestion -Runny nose -Shortness of breath or difficulty breathing with exertion -Muscle or body aches -Fatigue -Fever > 38.0◦C -Chills -Headache -Nausea -Vomiting -Diarrhea -Loss of smell -Loss of taste 3. Has mild or moderate COVID-19, participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. 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 longterm and persistent basis), for 28 days from 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 (urine or serum as required by local regulations) 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. 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 the 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 ≤7 days prior to the day of randomization. 2. Had initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to the day of randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization: -Cough -Sore throat -Nasal congestion -Runny nose -Shortness of breath or difficulty breathing with exertion -Muscle or body aches -Fatigue -Fever > 38.0◦C -Chills -Headache -Nausea -Vomiting -Diarrhea -Loss of smell -Loss of taste 3. Has mild or moderate COVID-19, participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. 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 longterm and persistent basis), for 28 days from 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 (urine or serum as required by local regulations) 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. 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 the Protocol. 8. Participant (or legally acceptable representative) has provided documented informed consent for the study.

Dec. 10, 2020, 1:30 a.m. eu

1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤7 days prior to randomization. 2. Has initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization: -Cough -Sore throat -Nasal congestion -Runny nose -Shortness of breath or difficulty breathing -Muscle or body aches -Fatigue -Fever 38.0◦C -Chills -Headache -Nausea -Vomiting -Diarrhea -Loss of smell -Loss of taste 3. Has mild or moderate COVID-19, participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. 4. Has oxygenation saturation of >93% (on room air OR on supplemental oxygen prior to randomization which has not increased since onset of COVID-19 signs/symptoms) obtained at rest by study staff at randomization. 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 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 (urine or serum as required by local regulations) 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. 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 the 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 ≤7 days prior to randomization. 2. Has initial onset of signs/symptoms attributable to COVID-19 for ≤7 days prior to randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization: -Cough -Sore throat -Nasal congestion -Runny nose -Shortness of breath or difficulty breathing -Muscle or body aches -Fatigue -Fever 38.0◦C -Chills -Headache -Nausea -Vomiting -Diarrhea -Loss of smell -Loss of taste 3. Has mild or moderate COVID-19, participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. 4. Has oxygenation saturation of >93% (on room air OR on supplemental oxygen prior to randomization which has not increased since onset of COVID-19 signs/symptoms) obtained at rest by study staff at randomization. 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 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 (urine or serum as required by local regulations) 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. 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 the Protocol. 9. Participant (or legally acceptable representative) has provided documented informed consent for the study.