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

inclusion criteria: * are currently not hospitalized. (not applicable to participants in treatment arm 22.) * have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (not applicable to participants in treatment arm 22.) * must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion * are males or females, including pregnant females who agree to contraceptive requirements * understand and agree to comply with planned study procedures * agree to the collection of nasopharyngeal swabs and venous blood. (not applicable to participants in treatment arms 20-21.) * the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-21 only * are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening * are pregnant * are ≥65 years of age * have a body mass index (bmi) ≥35 * have chronic kidney disease (ckd) * have type 1 or type 2 diabetes * have immunosuppressive disease * are currently receiving immunosuppressive treatment or * are ≥55 years of age and have: * cardiovascular disease (cvd), or * hypertension, or * chronic obstructive pulmonary disease (copd) or other chronic respiratory disease * are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening * are pregnant * have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm * have sickle cell disease * have congenital or acquired heart disease * have neurodevelopmental disorders, for example, cerebral palsy * have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) * have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control * have type 1 or type 2 diabetes * have chronic kidney disease * have immunosuppressive disease, or * are currently receiving immunosuppressive treatment participants in treatment arm 22 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms \[kg\]) to 17 years of age (inclusive) and satisfy at least one of the following risk factors at the time of screening * are pregnant * have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm * have sickle cell disease * have congenital or acquired heart disease * have neurodevelopmental disorders, for example, cerebral palsy, autism, or down syndrome (fair health 2020; spreat et al. 2020) * have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) * have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control * have type 1 or type 2 diabetes * have chronic kidney disease * have immunosuppressive disease, or * are currently receiving immunosuppressive treatment, or * are less than (\<) one year of age. * have one or more covid-19 symptoms * shortness of breath/difficulty breathing * fever * sore throat * nausea * diarrhea * tiredness * headache * new loss of taste * nasal congestion/runny nose * chills * stomachache * vomiting * cough * muscle/body aches and pain * new loss of smell * poor appetite or poor feeding (in babies) participants in treatment arm 23 only: must have first positive result sample of current sars-cov-2 viral infection ≤3 days prior to start of treatment administration. participant can have covid previously and still meet criteria for this addendum. positive result needs to be from a current infection. are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to \<12 years of age at the time of screening, or are 12 to 17 and weighing \<40 kg; and * have mild to moderate covid-19 disease, including one or more covid-19 symptoms within the last 7 days * shortness of breath/difficulty breathing * fever * sore throat * nausea * diarrhea * tiredness * headache * new loss of taste * nasal congestion/runny nose * chills * malaise * vomiting * cough * muscle/body aches and pain * new loss of smell * poor appetite or poor feeding (in babies under 1 year old)

inclusion criteria: * are currently not hospitalized. (not applicable to participants in treatment arm 22.) * have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (not applicable to participants in treatment arm 22.) * must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion * are males or females, including pregnant females who agree to contraceptive requirements * understand and agree to comply with planned study procedures * agree to the collection of nasopharyngeal swabs and venous blood. (not applicable to participants in treatment arms 20-21.) * the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-21 only * are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening * are pregnant * are ≥65 years of age * have a body mass index (bmi) ≥35 * have chronic kidney disease (ckd) * have type 1 or type 2 diabetes * have immunosuppressive disease * are currently receiving immunosuppressive treatment or * are ≥55 years of age and have: * cardiovascular disease (cvd), or * hypertension, or * chronic obstructive pulmonary disease (copd) or other chronic respiratory disease * are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening * are pregnant * have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm * have sickle cell disease * have congenital or acquired heart disease * have neurodevelopmental disorders, for example, cerebral palsy * have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) * have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control * have type 1 or type 2 diabetes * have chronic kidney disease * have immunosuppressive disease, or * are currently receiving immunosuppressive treatment participants in treatment arm 22 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms \[kg\]) to 17 years of age (inclusive) and satisfy at least one of the following risk factors at the time of screening * are pregnant * have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm * have sickle cell disease * have congenital or acquired heart disease * have neurodevelopmental disorders, for example, cerebral palsy, autism, or down syndrome (fair health 2020; spreat et al. 2020) * have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) * have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control * have type 1 or type 2 diabetes * have chronic kidney disease * have immunosuppressive disease, or * are currently receiving immunosuppressive treatment, or * are less than (\<) one year of age. * have one or more covid-19 symptoms * shortness of breath/difficulty breathing * fever * sore throat * nausea * diarrhea * tiredness * headache * new loss of taste * nasal congestion/runny nose * chills * stomachache * vomiting * cough * muscle/body aches and pain * new loss of smell * poor appetite or poor feeding (in babies) participants in treatment arm 23 only: must have first positive result sample of current sars-cov-2 viral infection ≤3 days prior to start of treatment administration. participant can have covid previously and still meet criteria for this addendum. positive result needs to be from a current infection. are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to \<12 years of age at the time of screening, or are 12 to 17 and weighing \<40 kg; and * have mild to moderate covid-19 disease, including one or more covid-19 symptoms within the last 7 days * shortness of breath/difficulty breathing * fever * sore throat * nausea * diarrhea * tiredness * headache * new loss of taste * nasal congestion/runny nose * chills * malaise * vomiting * cough * muscle/body aches and pain * new loss of smell * poor appetite or poor feeding (in babies under 1 year old)

Sept. 1, 2022, 10 p.m. usa

inclusion criteria: are currently not hospitalized. (not applicable to participants in treatment arm 22.) have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (not applicable to participants in treatment arm 22.) must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion are males or females, including pregnant females who agree to contraceptive requirements understand and agree to comply with planned study procedures agree to the collection of nasopharyngeal swabs and venous blood. (not applicable to participants in treatment arms 20-21.) the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-21 only are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening are pregnant are ≥65 years of age have a body mass index (bmi) ≥35 have chronic kidney disease (ckd) have type 1 or type 2 diabetes have immunosuppressive disease are currently receiving immunosuppressive treatment or are ≥55 years of age and have: cardiovascular disease (cvd), or hypertension, or chronic obstructive pulmonary disease (copd) or other chronic respiratory disease are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening are pregnant have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm have sickle cell disease have congenital or acquired heart disease have neurodevelopmental disorders, for example, cerebral palsy have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control have type 1 or type 2 diabetes have chronic kidney disease have immunosuppressive disease, or are currently receiving immunosuppressive treatment participants in treatment arm 22 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) and satisfy at least one of the following risk factors at the time of screening are pregnant have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm have sickle cell disease have congenital or acquired heart disease have neurodevelopmental disorders, for example, cerebral palsy, autism, or down syndrome (fair health 2020; spreat et al. 2020) have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control have type 1 or type 2 diabetes have chronic kidney disease have immunosuppressive disease, or are currently receiving immunosuppressive treatment, or are less than (<) one year of age. have one or more covid-19 symptoms shortness of breath/difficulty breathing fever sore throat nausea diarrhea tiredness headache new loss of taste nasal congestion/runny nose chills stomachache vomiting cough muscle/body aches and pain new loss of smell poor appetite or poor feeding (in babies) participants in treatment arm 23 only: must have first positive result sample of current sars-cov-2 viral infection ≤3 days prior to start of treatment administration. participant can have covid previously and still meet criteria for this addendum. positive result needs to be from a current infection. are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to <12 years of age at the time of screening, or are 12 to 17 and weighing <40 kg; and have mild to moderate covid-19 disease, including one or more covid-19 symptoms within the last 7 days shortness of breath/difficulty breathing fever sore throat nausea diarrhea tiredness headache new loss of taste nasal congestion/runny nose chills malaise vomiting cough muscle/body aches and pain new loss of smell poor appetite or poor feeding (in babies under 1 year old)

inclusion criteria: are currently not hospitalized. (not applicable to participants in treatment arm 22.) have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (not applicable to participants in treatment arm 22.) must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion are males or females, including pregnant females who agree to contraceptive requirements understand and agree to comply with planned study procedures agree to the collection of nasopharyngeal swabs and venous blood. (not applicable to participants in treatment arms 20-21.) the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-21 only are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening are pregnant are ≥65 years of age have a body mass index (bmi) ≥35 have chronic kidney disease (ckd) have type 1 or type 2 diabetes have immunosuppressive disease are currently receiving immunosuppressive treatment or are ≥55 years of age and have: cardiovascular disease (cvd), or hypertension, or chronic obstructive pulmonary disease (copd) or other chronic respiratory disease are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening are pregnant have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm have sickle cell disease have congenital or acquired heart disease have neurodevelopmental disorders, for example, cerebral palsy have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control have type 1 or type 2 diabetes have chronic kidney disease have immunosuppressive disease, or are currently receiving immunosuppressive treatment participants in treatment arm 22 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) and satisfy at least one of the following risk factors at the time of screening are pregnant have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm have sickle cell disease have congenital or acquired heart disease have neurodevelopmental disorders, for example, cerebral palsy, autism, or down syndrome (fair health 2020; spreat et al. 2020) have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control have type 1 or type 2 diabetes have chronic kidney disease have immunosuppressive disease, or are currently receiving immunosuppressive treatment, or are less than (<) one year of age. have one or more covid-19 symptoms shortness of breath/difficulty breathing fever sore throat nausea diarrhea tiredness headache new loss of taste nasal congestion/runny nose chills stomachache vomiting cough muscle/body aches and pain new loss of smell poor appetite or poor feeding (in babies) participants in treatment arm 23 only: must have first positive result sample of current sars-cov-2 viral infection ≤3 days prior to start of treatment administration. participant can have covid previously and still meet criteria for this addendum. positive result needs to be from a current infection. are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to <12 years of age at the time of screening, or are 12 to 17 and weighing <40 kg; and have mild to moderate covid-19 disease, including one or more covid-19 symptoms within the last 7 days shortness of breath/difficulty breathing fever sore throat nausea diarrhea tiredness headache new loss of taste nasal congestion/runny nose chills malaise vomiting cough muscle/body aches and pain new loss of smell poor appetite or poor feeding (in babies under 1 year old)

March 31, 2021, 12:31 a.m. usa

inclusion criteria: - are currently not hospitalized. (not applicable to participants in treatment arm 22.) - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (not applicable to participants in treatment arm 22.) - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or females, including pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood. (not applicable to participants in treatment arms 20-21.) - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-21 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are pregnant - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - are pregnant - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment participants in treatment arm 22 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) and satisfy at least one of the following risk factors at the time of screening - are pregnant - have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy, autism, or down syndrome (fair health 2020; spreat et al. 2020) - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment, or - are less than (<) one year of age. - have one or more covid-19 symptoms - shortness of breath/difficulty breathing - fever - sore throat - nausea - diarrhea - tiredness - headache - new loss of taste - nasal congestion/runny nose - chills - stomachache - vomiting - cough - muscle/body aches and pain - new loss of smell - poor appetite or poor feeding (in babies)

inclusion criteria: - are currently not hospitalized. (not applicable to participants in treatment arm 22.) - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (not applicable to participants in treatment arm 22.) - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or females, including pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood. (not applicable to participants in treatment arms 20-21.) - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-21 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are pregnant - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - are pregnant - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment participants in treatment arm 22 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) and satisfy at least one of the following risk factors at the time of screening - are pregnant - have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy, autism, or down syndrome (fair health 2020; spreat et al. 2020) - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment, or - are less than (<) one year of age. - have one or more covid-19 symptoms - shortness of breath/difficulty breathing - fever - sore throat - nausea - diarrhea - tiredness - headache - new loss of taste - nasal congestion/runny nose - chills - stomachache - vomiting - cough - muscle/body aches and pain - new loss of smell - poor appetite or poor feeding (in babies)

March 18, 2021, 12:31 a.m. usa

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or females, including pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-19 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are pregnant - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - are pregnant - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment participants in treatment arm 15 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment, or - are less than (<) one year of age. participants in treatment arms 20 and 21 only - are ≥18 years of age and satisfy at least one of the following at the time of screening - are pregnant - are ≥ 65 years of age - have a bmi ≥ 35 - have chronic kidney disease - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment, or - are ≥ 55 years of age and have - cardiovascular disease, or - hypertension, or - chronic obstructive pulmonary disease or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - are pregnant - have a bmi ≥85th percentile for their age and gender based on cdc growth charts, - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or females, including pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13-14, and 18-19 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are pregnant - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - are pregnant - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment participants in treatment arm 15 only - are 0 (≥ 32 weeks gestational age and ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a bmi ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment, or - are less than (<) one year of age. participants in treatment arms 20 and 21 only - are ≥18 years of age and satisfy at least one of the following at the time of screening - are pregnant - are ≥ 65 years of age - have a bmi ≥ 35 - have chronic kidney disease - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment, or - are ≥ 55 years of age and have - cardiovascular disease, or - hypertension, or - chronic obstructive pulmonary disease or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - are pregnant - have a bmi ≥85th percentile for their age and gender based on cdc growth charts, - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control

Jan. 29, 2021, 12:31 a.m. usa

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or non-pregnant females, including pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13, and 14 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or non-pregnant females, including pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7-9, 13, and 14 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment

Dec. 18, 2020, 12:31 a.m. usa

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or non-pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7 and 8 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or non-pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7 and 8 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease - have type 1 or type 2 diabetes - have chronic kidney disease - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment

Nov. 11, 2020, 11:31 p.m. usa

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or non-pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7 and 8 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease - have type 1 or type 2 diabetes - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are males or non-pregnant females who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent and/or assent participants in treatment arms 7 and 8 only - are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening - are ≥65 years of age - have a body mass index (bmi) ≥35 - have chronic kidney disease (ckd) - have type 1 or type 2 diabetes - have immunosuppressive disease - are currently receiving immunosuppressive treatment or - are ≥55 years of age and have: - cardiovascular disease (cvd), or - hypertension, or - chronic obstructive pulmonary disease (copd) or other chronic respiratory disease - are 12-17 years of age (inclusive) and satisfy at least one of the following at the time of screening - have a body mass index (bmi) ≥85th percentile for their age and gender based on cdc growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm - have sickle cell disease - have congenital or acquired heart disease - have neurodevelopmental disorders, for example, cerebral palsy - have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to covid-19) - have asthma or reactive airway or other chronic respiratory disease - have type 1 or type 2 diabetes - have immunosuppressive disease, or - are currently receiving immunosuppressive treatment

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

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are men or non-pregnant women who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent - treatment arms 7 and 8 only: participants are greater than or equal to (≥) 65 years of age at the time of randomization or have a body mass index (bmi) ≥ 35 or are ≥ 55 years of age and have a bmi ≥ 30 and have a history of myocardial infarction or stroke

inclusion criteria: - are currently not hospitalized - have one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion - are men or non-pregnant women who agree to contraceptive requirements - understand and agree to comply with planned study procedures - agree to the collection of nasopharyngeal swabs and venous blood - the participant or legally authorized representative give signed informed consent - treatment arms 7 and 8 only: participants are greater than or equal to (≥) 65 years of age at the time of randomization or have a body mass index (bmi) ≥ 35 or are ≥ 55 years of age and have a bmi ≥ 30 and have a history of myocardial infarction or stroke