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

* severe or critical covid-19 illness * admitted to a hospital within 90 days prior to randomization due to covid-19 * use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study * initiation or planned initiation of remdesivir for treatment of the current sars-cov-2 infection * requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. note: subjects who had already initiated any covid-19 drug with antiviral effects intended to treat symptomatic sars-cov-2 infection (≥ 24 hours prior to randomization) will be excluded. during screening (or within 24 hours prior to or after randomization), locally available covid-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted. * other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (rsv). note: this exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis c virus (hcv) or hiv providing other eligibility criteria are met. * receiving dialysis or have known severe renal impairment * history of severe hepatic impairment (child-pugh class c) * known allergy or hypersensitivity to components of study drug

* severe or critical covid-19 illness * admitted to a hospital within 90 days prior to randomization due to covid-19 * use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study * initiation or planned initiation of remdesivir for treatment of the current sars-cov-2 infection * requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. note: subjects who had already initiated any covid-19 drug with antiviral effects intended to treat symptomatic sars-cov-2 infection (≥ 24 hours prior to randomization) will be excluded. during screening (or within 24 hours prior to or after randomization), locally available covid-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted. * other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (rsv). note: this exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis c virus (hcv) or hiv providing other eligibility criteria are met. * receiving dialysis or have known severe renal impairment * history of severe hepatic impairment (child-pugh class c) * known allergy or hypersensitivity to components of study drug

Aug. 26, 2023, 4 a.m. usa

severe or critical covid-19 illness admitted to a hospital within 90 days prior to randomization due to covid-19 use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study initiation or planned initiation of remdesivir for treatment of the current sars-cov-2 infection requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. note: subjects who had already initiated any covid-19 drug with antiviral effects intended to treat symptomatic sars-cov-2 infection (≥ 24 hours prior to randomization) will be excluded. during screening (or within 24 hours prior to or after randomization), locally available covid-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted. other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (rsv). note: this exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis c virus (hcv) or hiv providing other eligibility criteria are met. receiving dialysis or have known severe renal impairment history of severe hepatic impairment (child-pugh class c) known allergy or hypersensitivity to components of study drug

severe or critical covid-19 illness admitted to a hospital within 90 days prior to randomization due to covid-19 use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study initiation or planned initiation of remdesivir for treatment of the current sars-cov-2 infection requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. note: subjects who had already initiated any covid-19 drug with antiviral effects intended to treat symptomatic sars-cov-2 infection (≥ 24 hours prior to randomization) will be excluded. during screening (or within 24 hours prior to or after randomization), locally available covid-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted. other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (rsv). note: this exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis c virus (hcv) or hiv providing other eligibility criteria are met. receiving dialysis or have known severe renal impairment history of severe hepatic impairment (child-pugh class c) known allergy or hypersensitivity to components of study drug

Dec. 1, 2022, 4 p.m. usa

severe or critical covid-19 illness admitted to a hospital within 90 days prior to randomization due to covid-19 use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study initiation or planned initiation of remdesivir for treatment of the current sars-cov-2 infection requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. note: subjects who had already initiated any covid-19 drug with antiviral effects intended to treat symptomatic sars-cov-2 infection (≥ 24 hours prior to randomization) will be excluded. during screening (or within 24 hours prior to or after randomization), locally available covid-19 drugs with antiviral effects (including but not limited to paxlovid, molnupiravir, favipiravir, monoclonal antibodies) will be permitted, as long as there are no concerns for drug interactions. other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (rsv). note: this exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis c virus (hcv) or hiv providing other eligibility criteria are met. receiving dialysis or have known moderate to severe renal impairment history of severe hepatic impairment (child-pugh class c) known allergy or hypersensitivity to components of study drug

severe or critical covid-19 illness admitted to a hospital within 90 days prior to randomization due to covid-19 use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study initiation or planned initiation of remdesivir for treatment of the current sars-cov-2 infection requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. note: subjects who had already initiated any covid-19 drug with antiviral effects intended to treat symptomatic sars-cov-2 infection (≥ 24 hours prior to randomization) will be excluded. during screening (or within 24 hours prior to or after randomization), locally available covid-19 drugs with antiviral effects (including but not limited to paxlovid, molnupiravir, favipiravir, monoclonal antibodies) will be permitted, as long as there are no concerns for drug interactions. other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (rsv). note: this exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis c virus (hcv) or hiv providing other eligibility criteria are met. receiving dialysis or have known moderate to severe renal impairment history of severe hepatic impairment (child-pugh class c) known allergy or hypersensitivity to components of study drug