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

* inability to take oral medication at screening or baseline visit * evidence at screening or baseline of critical covid-19 disease (e.g., cardiac failure, septic shock) or severe pulmonary involvement) * positive pregnancy test at screening for women of childbearing potential * lactating female at baseline for women of childbearing potential note: a female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose * ≥5 × upper limit of normal (uln) for alanine or aspartate aminotransferases or total bilirubin \>1.5 × uln at screening or known history of child-pugh class c, hepatitis b or c, or hiv infection * glomerular filtration rate \<30 ml/min/1.73 m2 at screening * qtcf \>450 msec for male or \>470 msec for females or evidence of cardiac dysrhythmia at screening * significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion * has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (il)-6 inhibitors, tumor necrosis factor (tnf) inhibitors, anti-il-1 agents, and janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period * treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or soc any time during the study period * recent (within 30 days) or current participation in other covid-19 therapeutic trials or expanded access programs * prior or current participation in covid-19 vaccine trials

* inability to take oral medication at screening or baseline visit * evidence at screening or baseline of critical covid-19 disease (e.g., cardiac failure, septic shock) or severe pulmonary involvement) * positive pregnancy test at screening for women of childbearing potential * lactating female at baseline for women of childbearing potential note: a female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose * ≥5 × upper limit of normal (uln) for alanine or aspartate aminotransferases or total bilirubin \>1.5 × uln at screening or known history of child-pugh class c, hepatitis b or c, or hiv infection * glomerular filtration rate \<30 ml/min/1.73 m2 at screening * qtcf \>450 msec for male or \>470 msec for females or evidence of cardiac dysrhythmia at screening * significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion * has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (il)-6 inhibitors, tumor necrosis factor (tnf) inhibitors, anti-il-1 agents, and janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period * treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or soc any time during the study period * recent (within 30 days) or current participation in other covid-19 therapeutic trials or expanded access programs * prior or current participation in covid-19 vaccine trials

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

- inability to take oral medication at screening or baseline visit - evidence at screening or baseline of critical covid-19 disease (e.g., cardiac failure, septic shock) or severe pulmonary involvement) - positive pregnancy test at screening for women of childbearing potential - lactating female at baseline for women of childbearing potential note: a female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose - ≥5 × upper limit of normal (uln) for alanine or aspartate aminotransferases or total bilirubin >1.5 × uln at screening or known history of child-pugh class c, hepatitis b or c, or hiv infection - glomerular filtration rate <30 ml/min/1.73 m2 at screening - qtcf >450 msec for male or >470 msec for females or evidence of cardiac dysrhythmia at screening - significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion - has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (il)-6 inhibitors, tumor necrosis factor (tnf) inhibitors, anti-il-1 agents, and janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period - treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or soc any time during the study period - recent (within 30 days) or current participation in other covid-19 therapeutic trials or expanded access programs - prior or current participation in covid-19 vaccine trials

- inability to take oral medication at screening or baseline visit - evidence at screening or baseline of critical covid-19 disease (e.g., cardiac failure, septic shock) or severe pulmonary involvement) - positive pregnancy test at screening for women of childbearing potential - lactating female at baseline for women of childbearing potential note: a female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose - ≥5 × upper limit of normal (uln) for alanine or aspartate aminotransferases or total bilirubin >1.5 × uln at screening or known history of child-pugh class c, hepatitis b or c, or hiv infection - glomerular filtration rate <30 ml/min/1.73 m2 at screening - qtcf >450 msec for male or >470 msec for females or evidence of cardiac dysrhythmia at screening - significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion - has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (il)-6 inhibitors, tumor necrosis factor (tnf) inhibitors, anti-il-1 agents, and janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period - treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or soc any time during the study period - recent (within 30 days) or current participation in other covid-19 therapeutic trials or expanded access programs - prior or current participation in covid-19 vaccine trials