Safety and Pharmacokinetics of Casirivimab and Imdevimab (CAS + IMD) in Pediatric Outpatients With COVID-19
Related Experiment Video
Updated: Jun 11, 2025
Live Imaging and Quantification of Viral Infection in K18 hACE2 Transgenic Mice Using Reporter-Expressing Recombinant SARS-CoV-2
Published on: November 5, 2021
Thomas D Norton1, Mazhar Thakur1, Samit Ganguly1
1Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Insights
Casirivimab + imdevimab (CAS + IMD) monoclonal antibodies were safe for pediatric COVID-19 outpatients. This finding supports developing new SARS-CoV-2 antibody treatments for at-risk children.
Area of Science:
- Immunology
- Virology
- Pediatric Medicine
Background:
- Coronavirus disease 2019 (COVID-19) poses risks to pediatric populations.
- Monoclonal antibodies (mAbs) are a therapeutic option for COVID-19.
- Evaluating the safety and efficacy of mAbs in children is crucial.
Purpose of the Study:
- To assess the safety and tolerability of casirivimab + imdevimab (CAS + IMD) in pediatric outpatients with COVID-19.
- To evaluate drug-induced immunogenicity rates associated with CAS + IMD treatment in children.
- To inform the development of future anti-SARS-CoV-2 mAb therapies for pediatric use.
Main Methods:
- A randomized phase 1/2/3 clinical trial was conducted.
- Pediatric outpatients with COVID-19 received CAS + IMD.
- Safety endpoints and immunogenicity were monitored.
Main Results:
- CAS + IMD was generally well tolerated in pediatric outpatients.
- Low rates of drug-induced immunogenicity were observed.
- Safety profile was consistent with findings in adult populations.
Conclusions:
- CAS + IMD demonstrates a favorable safety profile in pediatric COVID-19 outpatients.
- The study supports the use of CAS + IMD in at-risk pediatric patients.
- Findings encourage the development of next-generation anti-SARS-CoV-2 mAbs for children.
Abstract:
The safety of casirivimab + imdevimab (CAS + IMD) (anti-severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] monoclonal antibodies [mAbs]) in pediatric outpatients with coronavirus disease 2019 (COVID-19) was evaluated in a randomized phase 1/2/3 trial. Consistent with adults, CAS + IMD was generally well tolerated with low drug-induced immunogenicity rates. The findings support the development of next-generation anti-SARS-CoV-2 mAbs for at-risk pediatric patients.
