COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19

Exclusion Criteria

• •1. In the opinion of the investigator, unlikely to survive for \>96 hours from screening
• •2. Neonates having gestational age of \<29 weeks and weight \<1.1 kg
• •3. Receiving extracorporeal membrane oxygenation (ECMO)
• •4. Has new-onset stroke or seizure disorder during hospitalization
• •5. Initiated on renal replacement therapy due to COVID-19
• •6. Has circulatory shock requiring vasopressors on dosing day Note: Patients who require vasopressors for sedation-related hypotension or reasons other than circulatory shock may be eligible in this study
• •7. Participation in a clinical research study, including any double-blind study, evaluating an investigational product within 30 days and less than 5 half-lives of the investigational product prior to the screening visit
• •8. Members of the clinical site study team and/or their immediate family
• •9. Plans to receive an investigational or approved SARS-CoV-2 vaccine within 90 days after study drug administration based on current Centers for Disease Control vaccination guidelines (CDC, 2021). Refer to the latest CDC guidance for any updates.
• •Note: Patients who have already completed vaccination prior to study enrollment may be allowed in the study.
• •10. Prior use (within 90 days prior to study drug administration) or current use of any investigational, authorized, or approved passive antibody for prophylaxis of SARS-CoV-2 infection, including convalescent plasma, convalescent sera, hyperimmune globulin, or other monoclonal antibodies (eg, bamlanivimab and etesevimab, sotrovimab)