Treatment of Infants and Children With SARS-CoV-2 Monoclonal Antibodies: A European Case Series

Abstract

Background: Although severe COVID-19 in children is rare, those with certain pre-existing health conditions are more prone to severe disease. Monoclonal antibodies (mAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are potent antiviral agents that reduce adverse clinical outcomes in adults, but are commonly not approved for use in pediatric patients. Methods: We retrospectively evaluated mAb treatment in children <12 years of age or <40kg with SARS-CoV-2 infection between January 1, 2021, and March 7, 2022, in 12 tertiary care centers in 3 European countries. Results: We received data from 53 patients from Austria, Denmark and Germany. Median age was 5.4 years [0–13.8, interquartile range (IQR) = 6.2], and median body weight was 20 kg (3–50.1, IQR = 13). The most frequent SARS-CoV-2 variant in this study, if known, was Omicron, followed by Delta and Alpha. Pre-existing conditions included immunodeficiency, malignancy, hematologic disease, cardiac disease, chronic lung disease, chronic liver disease, kidney disease and diabetes. Forty-two patients received sotrovimab (79%), 9 casirivimab/imdevimab (17%) and 2 bamlanivimab (4%). All but 1 patient survived. Median duration of hospital stay was 3 days (0–56, IQR = 6). Seven patients required treatment in an intensive care unit, and 5 required high-flow nasal cannula treatment. Potential side effects included neutropenia (6/53, 11%), lymphopenia (3/53, 6%), nausea or vomiting (2/53, 4%), rise of alanine transaminase (1/53, 2%) and hypotonia (1/53, 2%). Conclusions: MAb treatment was well tolerated by children in this cohort.

Use of Remdesivir in children with COVID-19: report of an Italian multicenter study

“…In addition, WHO and various guidelines based on large RCTs and systematic reviews suggest that in addition to RDV, corticosteroids, IVIG, tocilizumab, anakinra, infliximab, aspirin, and heparin, other drugs cannot be recommended in cases of COVID-19 in children of any severity [ 38 ]. Safety and efficacy data on the use of monoclonal antibodies are reported in the literature [ 38 – 41 ] and show good tolerance and safety, but clear data on efficacy in children are still limited. Ader et al published on 2022 the results of DisCoVeRy trial showing no clinical benefit from the use of Remdesivir in patients who were admitted to hospital for COVID-19 with symptoms for more than 7 days.…”

Demographic, clinical and laboratory differences between paediatric acute COVID-19 and PIMS-TS—results from a single centre study in the UK

“…Thus, pregnant women should not only be encouraged to receive vaccines due to the increased risk of developing severe disease themselves, but also to allow effective maternal antibody transfer that may potentially protect infants in the crucial first 6 months of life (64,65). As an alternative, in young children and infants who have not received vaccination, the use of neutralising monoclonal antibody products may incur survival benefit during severe acute COVID-19 disease (66), but more robust safety and efficacy data is required for its routine use.…”