Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

have spo2 ≤ 93% on room air at sea level or pao2/fio2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to covid-19 or requires treatment with supplemental oxygen have known allergies to any of the components used in the formulation of the study drug or placebo suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose prior, current, or planned future use of any of the following treatments at screening: covid-19 convalescent plasma, mabs against sars-cov-2, ivig (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening are investigator site personnel directly affiliated with this study have received an investigational intervention for sars-cov-2 prophylaxis within 30 days prior to randomization

have spo2 ≤ 93% on room air at sea level or pao2/fio2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to covid-19 or requires treatment with supplemental oxygen have known allergies to any of the components used in the formulation of the study drug or placebo suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose prior, current, or planned future use of any of the following treatments at screening: covid-19 convalescent plasma, mabs against sars-cov-2, ivig (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening are investigator site personnel directly affiliated with this study have received an investigational intervention for sars-cov-2 prophylaxis within 30 days prior to randomization

May 5, 2021, 11:25 a.m. usa

1. have spo2 ≤ 93% on room air at sea level or pao2/fio2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute 2. has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to covid-19 or requires treatment with supplemental oxygen 3. have known allergies to any of the components used in the formulation of the study drug or placebo 4. suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo 5. have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days 6. have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose 7. prior, current, or planned future use of any of the following treatments at screening: covid-19 convalescent plasma, mabs against sars-cov-2, ivig (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening 8. are investigator site personnel directly affiliated with this study 9. have received an investigational intervention for sars-cov-2 prophylaxis within 30 days prior to randomization

1. have spo2 ≤ 93% on room air at sea level or pao2/fio2 < 300, or a respiratory rate ≥30 per minute, or a heart rate ≥125 per minute 2. has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to covid-19 or requires treatment with supplemental oxygen 3. have known allergies to any of the components used in the formulation of the study drug or placebo 4. suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) requiring systemic therapy and that in the opinion of the investigator could constitute a risk to the subject or study assessments when taking study drug or placebo 5. have any co-morbidity anticipated to require surgery within <7 days, or that is considered life threatening within 30 days 6. have received treatment with the anti-androgen agents or 5-alpha reductase inhibitors within 3 months of the first dose 7. prior, current, or planned future use of any of the following treatments at screening: covid-19 convalescent plasma, mabs against sars-cov-2, ivig (any indication), where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening 8. are investigator site personnel directly affiliated with this study 9. have received an investigational intervention for sars-cov-2 prophylaxis within 30 days prior to randomization