Pediatric Inclusion Criteria (must meet ALL): Between 12 and 18 years of age; at least 88 pounds (40kg); laboratory confirmed COVID-19 (PCR or Antigen); symptomatic, with no more than 10 days from symptom onset; NOT hospitalized; NOT pregnant; and have B-cell immunodeficiency [primary or acquired (e.g. rituximab therapy, certain types of cancer treatment that are B-cell depleting therapies)].
Pediatric Criteria Rationale: Children have a lower risk of hospitalization from COVID-19 infection than adults and therefore are less likely to benefit from monoclonal antibody therapy. Studies using COVID-19 monoclonal antibody therapy have NOT included children so it is unclear if children would benefit from the drug. In addition to the uncertainty of benefit, although rare, there is a risk of anaphylaxis and infusion related reaction with the administration of the COVID-19 antibody therapy. We do not have enough information to know if the potential benefits of this therapy in children outweigh the risks.
A serious effect of COVID-19 in children is multisystem inflammatory syndrome in children (MIS-C). This is a condition where multiple organs such as the heart, lungs, brain, kidneys, skin, eyes, and gastrointestinal system become inflamed. Although we do not fully understand what causes this, antibodies to COVID-19 are found in the blood of most children with MIS-C. We do NOT know the effect of COVID-19 monoclonal antibody therapy on risk of MIS-C.
Given that children are less likely to benefit from COVID-19 monoclonal antibody than adults (even adolescents with high-risk conditions), the unknown benefit and the lack of safety information for this drug in children, monoclonal antibody therapy should be considered experimental and should only be considered for children at highest risk of serious complication.
Below are the children that may be considered on a case-by-case basis for therapy. If your child meets the criteria below and you are interested in COVID-19 monoclonal antibody therapy, please talk with your child’s specialist physician (e.g. rheumatologist, immunologist, or oncologist). If you and your child’s provider determine that your child meets the eligibility criteria, your provider can call a member of the children’s infectious diseases or rheumatology team to further discuss eligibility and next steps.
Providers should send an email regarding eligible pediatric patients to: Pediatric.MonoclonalAntibodies@imail.org
