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

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