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

1. weighs \<40 kg (only applies to participants ≥12 to \<18 years of age) 2. has any signs or symptoms consistent with covid-19 3. past covid-19 infection within 90 days prior to randomization 4. planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug 5. prior, current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment 6. is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening 7. has any known active acute respiratory infection 8. has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection 9. has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

1. weighs \<40 kg (only applies to participants ≥12 to \<18 years of age) 2. has any signs or symptoms consistent with covid-19 3. past covid-19 infection within 90 days prior to randomization 4. planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug 5. prior, current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment 6. is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening 7. has any known active acute respiratory infection 8. has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection 9. has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

Feb. 24, 2022, 6:30 p.m. usa

weighs <40 kg (only applies to participants ≥12 to <18 years of age) has any signs or symptoms consistent with covid-19 past covid-19 infection within 90 days prior to randomization planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug prior, current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening has any known active acute respiratory infection has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

weighs <40 kg (only applies to participants ≥12 to <18 years of age) has any signs or symptoms consistent with covid-19 past covid-19 infection within 90 days prior to randomization planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug prior, current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening has any known active acute respiratory infection has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

Nov. 16, 2021, 6:30 p.m. usa

weighs <40 kg (only applies to participants ≥12 to <18 years of age) has any signs or symptoms consistent with covid-19 past covid-19 infection within 90 days prior to randomization planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug prior (within 30 days), current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening has any known active acute respiratory infection has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

weighs <40 kg (only applies to participants ≥12 to <18 years of age) has any signs or symptoms consistent with covid-19 past covid-19 infection within 90 days prior to randomization planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug prior (within 30 days), current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening has any known active acute respiratory infection has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

Oct. 14, 2021, 2:24 p.m. usa

1. weighs <40 kg (only applies to participants ≥12 to <18 years of age) 2. has any signs or symptoms consistent with covid-19 3. past covid-19 infection within 90 days prior to randomization 4. planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug 5. prior (within 30 days), current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment 6. is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening 7. has any known active acute respiratory infection 8. has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection 9. has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply

1. weighs <40 kg (only applies to participants ≥12 to <18 years of age) 2. has any signs or symptoms consistent with covid-19 3. past covid-19 infection within 90 days prior to randomization 4. planned use of any investigational, authorized, or approved vaccine for covid-19 within 90 days of the last dose of study drug 5. prior (within 30 days), current, or planned use of any of covid-19 convalescent plasma, other monoclonal antibodies against sars-cov-2 or any covid-19 treatment 6. is planned to begin immunoglobulin (ivig) or immunoglobulin (scig) therapy, is planned to have a change to existing ivig or scig, or has been on a chronic stable dose of their ivig or scig regimen for less than 90 days prior to screening 7. has any known active acute respiratory infection 8. has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection 9. has known allergy or hypersensitivity to components of the study drugs note: other protocol defined inclusion/exclusion criteria apply