COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

Exclusion Criteria

• •1. Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
• •2. Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
• •3. Prior use of casirivimab+imdevimab at any time prior to randomization
• •4. Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)
• •5. Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening
• •6. Body mass index (BMI) ≥28 kg/m2
• •7. Medically-attended acute illness, systemic antibiotics use, or hospitalization for any reason within 30 days prior to screening
• •8. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening
• •9. Uncontrolled hypertension, in the opinion of the investigator
• •10. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening
• •11. Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ
• •12. Is pregnant at screening