COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease

Exclusion Criteria

• •4. Maintains O2 saturation ≥93% on room air
• •1. Has a medical condition or other factors associated with high risk for progression to severe COVID-19:
• •1. Cancer
• •2. Cardiovascular disease (such as heart failure, coronary artery disease, cardiomyopathies, congenital heart disease or hypertension)
• •3. Chronic lung disease including chronic obstructive pulmonary disease, asthma (moderate to severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
• •4. Chronic kidney disease at any stage
• •5. Chronic liver disease (such as alcohol-related, nonalcoholic fatty liver disease, cirrhosis)
• •6. Dementia or other chronic neurological condition
• •7. Diabetes mellitus (type 1 or type 2)
• •8. Immunodeficiency disease or taking immunosuppressive treatment
• •9. Medical-related technological dependence \[for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)\]
• •10. Neurodevelopmental disorder (for example, cerebral palsy) or other condition that confers medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
• •11. Overweight (defined as BMI \>25 kg/m2) or obesity (defined as BMI ≥30 kg/m2)
• •12. Poorly controlled HIV infection or AIDS
• •13. Pregnancy
• •14. Sickle cell disease or thalassemia
• •15. Stroke or cerebrovascular disease
• •2. Prior, current (at randomization) or planned use (within time period given per CDC guidance \[90 days\]) of any authorized or approved vaccine for COVID-19
• •3. Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
• •4. Has a known prior SARS-CoV-2 infection or positive SARS-CoV-2 serologic test
• •5. Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected \>72 hours prior to randomization
• •6. Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
• •7. Prior, current, or any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
• •8. Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
• •9. Has been discharged, or is planned to be discharged, to a quarantine center
• •10. Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19
• •11. For Phase 1only: Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and for at least 6 months after study drug administration as described in the protocol