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

inclusion criteria: * has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤5 days prior to the day of randomization. pcr is the preferred method; however with evolving approaches to laboratory confirmation of sars-cov-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (rna) or protein are allowed if authorized for use in the country. serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. * had initial onset of signs/symptoms attributable to covid-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to covid-19 on the day of randomization. * has mild or moderate covid-19. * has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from covid-19. * males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: either abstain 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. * females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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) for at least 4 days after the last dose of study intervention; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

inclusion criteria: * has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤5 days prior to the day of randomization. pcr is the preferred method; however with evolving approaches to laboratory confirmation of sars-cov-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (rna) or protein are allowed if authorized for use in the country. serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. * had initial onset of signs/symptoms attributable to covid-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to covid-19 on the day of randomization. * has mild or moderate covid-19. * has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from covid-19. * males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: either abstain 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. * females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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) for at least 4 days after the last dose of study intervention; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

May 29, 2021, 12:32 a.m. usa

inclusion criteria: - has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤5 days prior to the day of randomization. pcr is the preferred method; however with evolving approaches to laboratory confirmation of sars-cov-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (rna) or protein are allowed if authorized for use in the country. serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. - had initial onset of signs/symptoms attributable to covid-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to covid-19 on the day of randomization. - has mild or moderate covid-19. - has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from covid-19. - males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: either abstain 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. - females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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) for at least 4 days after the last dose of study intervention; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

inclusion criteria: - has documentation of laboratory confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤5 days prior to the day of randomization. pcr is the preferred method; however with evolving approaches to laboratory confirmation of sars-cov-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (rna) or protein are allowed if authorized for use in the country. serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. - had initial onset of signs/symptoms attributable to covid-19 for ≤5 days prior to the day of randomization and at least 1 of the following sign/symptom attributable to covid-19 on the day of randomization. - has mild or moderate covid-19. - has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from covid-19. - males agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: either abstain 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. - females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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) for at least 4 days after the last dose of study intervention; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

Dec. 26, 2020, 12:31 a.m. usa

inclusion criteria: - has documentation of polymerase chain reaction (pcr) confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤7 days prior to the day of randomization. pcr is the preferred method; however with evolving approaches to laboratory confirmation of sars-cov-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (rna) or protein are allowed if authorized for use in the country. serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. - 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 sign/symptom attributable to covid-19 on the day of randomization. - 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. - males 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; and either abstain 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. - females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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) for 28 days from the start of study intervention; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

inclusion criteria: - has documentation of polymerase chain reaction (pcr) confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤7 days prior to the day of randomization. pcr is the preferred method; however with evolving approaches to laboratory confirmation of sars-cov-2 infection, other molecular or antigen tests that detect viral ribonucleic acid (rna) or protein are allowed if authorized for use in the country. serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. - 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 sign/symptom attributable to covid-19 on the day of randomization. - 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. - males 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; and either abstain 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. - females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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) for 28 days from the start of study intervention; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

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

inclusion criteria: - has documentation of polymerase chain reaction (pcr)-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤7 days prior to randomization. pcr is the preferred method; however other diagnostic methods are allowed if authorized by use in the country. - has initial onset of signs/symptoms attributable to covid-19 for ≤7 days prior to randomization and at least 1 sign/symptom attributable to covid-19 on the day of randomization - 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 - 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. - is willing and able to take oral medication - males 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; and either abstain 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 - females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.

inclusion criteria: - has documentation of polymerase chain reaction (pcr)-confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with sample collection ≤7 days prior to randomization. pcr is the preferred method; however other diagnostic methods are allowed if authorized by use in the country. - has initial onset of signs/symptoms attributable to covid-19 for ≤7 days prior to randomization and at least 1 sign/symptom attributable to covid-19 on the day of randomization - 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 - 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. - is willing and able to take oral medication - males 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; and either abstain 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 - females are not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (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; a wocbp must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention.