Created at Source Raw Value Validated value
July 13, 2021, 10:30 p.m. eu

1. Is currently hospitalized or in the opinion of the investigator requires urgent medical attention or is anticipated to require hospitalization within 48 hours of randomization 2. Has oxygen saturation (SpO2) ≤93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300 mmHg, respiratory rate ≥30 per minute, or heart rate ≥125 per minute. 3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the opinion of the investigator anticipated impending need for mechanical ventilation. 4. Has a history of a positive SARS CoV 2 antibody serology test. Note: serology testing is not required for study eligibility, exclusion criterion is based on known history only. 5. Has participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients. 7. Has received a SARS CoV 2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID 19 any time prior to participation in the study. 8. Has a known active co infection (eg, influenza, urinary tract infection, etc). 9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study including but not limited to any co-morbidity requiring surgery or conditions considered life-threatening within 29 days. 10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. 11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) who is an investigator or site or sponsor staff (or designee) directly involved with the study.

1. Is currently hospitalized or in the opinion of the investigator requires urgent medical attention or is anticipated to require hospitalization within 48 hours of randomization 2. Has oxygen saturation (SpO2) ≤93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300 mmHg, respiratory rate ≥30 per minute, or heart rate ≥125 per minute. 3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the opinion of the investigator anticipated impending need for mechanical ventilation. 4. Has a history of a positive SARS CoV 2 antibody serology test. Note: serology testing is not required for study eligibility, exclusion criterion is based on known history only. 5. Has participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients. 7. Has received a SARS CoV 2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID 19 any time prior to participation in the study. 8. Has a known active co infection (eg, influenza, urinary tract infection, etc). 9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study including but not limited to any co-morbidity requiring surgery or conditions considered life-threatening within 29 days. 10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. 11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) who is an investigator or site or sponsor staff (or designee) directly involved with the study.