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

1. has one or more symptoms suggestive of more severe illness with covid-19 and/or requires hospitalization. 2. is asymptomatic at screening or randomization, regardless of a positive covid-19 test. 3. is at increased risk of severe covid-19 for any reason including but not limited to: cancer (basal cell carcinoma and prostate carcinoma in situ \[gleason ≤ 6\] are acceptable), chronic kidney disease, chronic obstructive pulmonary disease, heart condition (congestive heart failure ii, iii and iv as per new york heart association: coronary disease and any other cardiac condition that imposes high risk of developing severe covid-19), immunocompromised state from solid organ transplant, sickle cell disease, or other condition, autoimmune disease, use of immunosuppressants (including high doses of systemic corticosteroids), type 1 or type 2 diabetes mellitus, current or prior history of smoking or vaping any product, including nicotine or thc. 4. has any active infection, other than the underlying covid-19. 5. has been admitted to a hospital within 3 months prior to randomization (except for planned admissions for minor procedures). 6. has been hospitalized due to covid-19 at any time. 7. has participated or is participating in a clinical research study currently or within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. 8. has received monoclonal antibodies against sars-cov-2 and/or covid-19 convalescent plasma. 9. is anticipated to be treated with any approved or investigational drug or agent against sars-cov-2 (other than the study drug) during the study including antiviral drug(s), antibodies, or convalescent plasma. 10. has received any covid-19 directed treatment in the 3 months prior to the screening visit including but not limited to: intravenous immunoglobulin, approved drugs or products used off label for treatment of covid-19, other experimental interventions. 11. has received a covid-19 vaccination within 6 weeks of screening. subjects vaccinated ≥ 6 weeks prior to screening and who otherwise meet inclusion/exclusion criteria are eligible to participate. 12. history or suspicion of excessive alcohol use (defined as drinking on average 14 drinks a week for males and 7 drinks a week for females) or of binge drinking (defined as 4 drinks on any day for males and 3 drinks on any day for females, for 5 or more days in the past month) 13. history of substance abuse or current use of any drugs of abuse 14. any other condition or prior therapy which the principal investigator feels may jeopardize the safety of the subject or the objectives of the study. note: other protocol defined inclusion/exclusion criteria apply

1. has one or more symptoms suggestive of more severe illness with covid-19 and/or requires hospitalization. 2. is asymptomatic at screening or randomization, regardless of a positive covid-19 test. 3. is at increased risk of severe covid-19 for any reason including but not limited to: cancer (basal cell carcinoma and prostate carcinoma in situ \[gleason ≤ 6\] are acceptable), chronic kidney disease, chronic obstructive pulmonary disease, heart condition (congestive heart failure ii, iii and iv as per new york heart association: coronary disease and any other cardiac condition that imposes high risk of developing severe covid-19), immunocompromised state from solid organ transplant, sickle cell disease, or other condition, autoimmune disease, use of immunosuppressants (including high doses of systemic corticosteroids), type 1 or type 2 diabetes mellitus, current or prior history of smoking or vaping any product, including nicotine or thc. 4. has any active infection, other than the underlying covid-19. 5. has been admitted to a hospital within 3 months prior to randomization (except for planned admissions for minor procedures). 6. has been hospitalized due to covid-19 at any time. 7. has participated or is participating in a clinical research study currently or within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. 8. has received monoclonal antibodies against sars-cov-2 and/or covid-19 convalescent plasma. 9. is anticipated to be treated with any approved or investigational drug or agent against sars-cov-2 (other than the study drug) during the study including antiviral drug(s), antibodies, or convalescent plasma. 10. has received any covid-19 directed treatment in the 3 months prior to the screening visit including but not limited to: intravenous immunoglobulin, approved drugs or products used off label for treatment of covid-19, other experimental interventions. 11. has received a covid-19 vaccination within 6 weeks of screening. subjects vaccinated ≥ 6 weeks prior to screening and who otherwise meet inclusion/exclusion criteria are eligible to participate. 12. history or suspicion of excessive alcohol use (defined as drinking on average 14 drinks a week for males and 7 drinks a week for females) or of binge drinking (defined as 4 drinks on any day for males and 3 drinks on any day for females, for 5 or more days in the past month) 13. history of substance abuse or current use of any drugs of abuse 14. any other condition or prior therapy which the principal investigator feels may jeopardize the safety of the subject or the objectives of the study. note: other protocol defined inclusion/exclusion criteria apply

June 24, 2022, 9 p.m. usa

has one or more symptoms suggestive of more severe illness with covid-19 and/or requires hospitalization. is asymptomatic at screening or randomization, regardless of a positive covid-19 test. is at increased risk of severe covid-19 for any reason including but not limited to: cancer (basal cell carcinoma and prostate carcinoma in situ [gleason ≤ 6] are acceptable), chronic kidney disease, chronic obstructive pulmonary disease, heart condition (congestive heart failure ii, iii and iv as per new york heart association: coronary disease and any other cardiac condition that imposes high risk of developing severe covid-19), immunocompromised state from solid organ transplant, sickle cell disease, or other condition, autoimmune disease, use of immunosuppressants (including high doses of systemic corticosteroids), type 1 or type 2 diabetes mellitus, current or prior history of smoking or vaping any product, including nicotine or thc. has any active infection, other than the underlying covid-19. has been admitted to a hospital within 3 months prior to randomization (except for planned admissions for minor procedures). has been hospitalized due to covid-19 at any time. has participated or is participating in a clinical research study currently or within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. has received monoclonal antibodies against sars-cov-2 and/or covid-19 convalescent plasma. is anticipated to be treated with any approved or investigational drug or agent against sars-cov-2 (other than the study drug) during the study including antiviral drug(s), antibodies, or convalescent plasma. has received any covid-19 directed treatment in the 3 months prior to the screening visit including but not limited to: intravenous immunoglobulin, approved drugs or products used off label for treatment of covid-19, other experimental interventions. has received a covid-19 vaccination within 6 weeks of screening. subjects vaccinated ≥ 6 weeks prior to screening and who otherwise meet inclusion/exclusion criteria are eligible to participate. history or suspicion of excessive alcohol use (defined as drinking on average 14 drinks a week for males and 7 drinks a week for females) or of binge drinking (defined as 4 drinks on any day for males and 3 drinks on any day for females, for 5 or more days in the past month) history of substance abuse or current use of any drugs of abuse any other condition or prior therapy which the principal investigator feels may jeopardize the safety of the subject or the objectives of the study. note: other protocol defined inclusion/exclusion criteria apply

has one or more symptoms suggestive of more severe illness with covid-19 and/or requires hospitalization. is asymptomatic at screening or randomization, regardless of a positive covid-19 test. is at increased risk of severe covid-19 for any reason including but not limited to: cancer (basal cell carcinoma and prostate carcinoma in situ [gleason ≤ 6] are acceptable), chronic kidney disease, chronic obstructive pulmonary disease, heart condition (congestive heart failure ii, iii and iv as per new york heart association: coronary disease and any other cardiac condition that imposes high risk of developing severe covid-19), immunocompromised state from solid organ transplant, sickle cell disease, or other condition, autoimmune disease, use of immunosuppressants (including high doses of systemic corticosteroids), type 1 or type 2 diabetes mellitus, current or prior history of smoking or vaping any product, including nicotine or thc. has any active infection, other than the underlying covid-19. has been admitted to a hospital within 3 months prior to randomization (except for planned admissions for minor procedures). has been hospitalized due to covid-19 at any time. has participated or is participating in a clinical research study currently or within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. has received monoclonal antibodies against sars-cov-2 and/or covid-19 convalescent plasma. is anticipated to be treated with any approved or investigational drug or agent against sars-cov-2 (other than the study drug) during the study including antiviral drug(s), antibodies, or convalescent plasma. has received any covid-19 directed treatment in the 3 months prior to the screening visit including but not limited to: intravenous immunoglobulin, approved drugs or products used off label for treatment of covid-19, other experimental interventions. has received a covid-19 vaccination within 6 weeks of screening. subjects vaccinated ≥ 6 weeks prior to screening and who otherwise meet inclusion/exclusion criteria are eligible to participate. history or suspicion of excessive alcohol use (defined as drinking on average 14 drinks a week for males and 7 drinks a week for females) or of binge drinking (defined as 4 drinks on any day for males and 3 drinks on any day for females, for 5 or more days in the past month) history of substance abuse or current use of any drugs of abuse any other condition or prior therapy which the principal investigator feels may jeopardize the safety of the subject or the objectives of the study. note: other protocol defined inclusion/exclusion criteria apply