for people ages up to 17 years (full criteria)
at Memphis, Tennessee and other locations
study started



The primary objectives of the study are: - To characterize the concentrations of casirivimab+imdevimab in serum over time - To evaluate the safety and tolerability of casirivimab+imdevimab The secondary objective of the study is: • To assess the immunogenicity of casirivimab+imdevimab

Official Title

A Phase 1b, Open-Label, Single Dose Study Assessing the 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


COVID-19, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus, casirivimab+imdevimab


You can join if…

Open to people ages up to 17 years

  1. Has SARS-CoV-2 positive antigen or molecular diagnostic test ≤72 hours prior to study enrollment Note: historical record of positive result is acceptable as long as the sample was collected ≤72 hours prior to enrollment
  2. Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤ 14 days before dosing
  3. Hospitalized due to COVID-19
  4. Provide informed consent signed by study patient or legally acceptable representative/guardian

You CAN'T join if...

  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.

  1. . 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)

Note: Other protocol defined Inclusion/ Exclusion criteria apply


  • Le Bonheur Children's Hospital
    Memphis Tennessee 38103 United States
  • State University of New York at Stony Brook
    Stony Brook New York 11794 United States


accepting new patients
Start Date
Completion Date
Regeneron Pharmaceuticals
Sign up for this study
Phase 1 COVID-19 Research Study
Study Type
About 2 people participating
Last Updated