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Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study

Authors :
Chiara Minotti
Daniele Mengato
Marica De Pieri
Sabrina Trivellato
Andrea Francavilla
Costanza Di Chiara
Cecilia Liberati
Raffaele Mattera
Alessandra Biffi
Carlo Giaquinto
Francesca Venturini
Daniele Donà
Source :
Viruses, Vol 15, Iss 1, p 192 (2023)
Publication Year :
2023
Publisher :
MDPI AG, 2023.

Abstract

(1) Background: SARS-CoV-2 infection is notably mild in children, though comorbidities may increase the risk of hospitalization and may represent a risk for increased disease severity. There is an urgent need for targeted therapies with an acceptable efficacy and safety profile. To date, most of the medicines for COVID-19-specific treatment are prescribed off-label for children due to a lack of clinical trials and consequent evidence in this population. (2) Methods: This was a retrospective, observational study investigating the safety of treatments for the prevention of severe COVID-19 in fragile pediatric patients who received monoclonal antibodies and antivirals for mild-to-moderate symptoms between December 2021 and July 2022. (3) Results: Thirty-two patients were included. Monoclonal antibodies were prescribed to 62%, intravenous antivirals to 22%, and oral antivirals to 16% of children. Sotrovimab was the most frequently prescribed drug among monoclonal antibodies and overall (59%). The second most prescribed drug was remdesivir (22%). No severe adverse drug reaction was reported. There was no progression to severe disease and no death cases due to COVID-19 or drug administration. At drug-type stratification, resolution of symptoms and swab positivity time showed no difference between the two groups at 7 and 28 days. Off-label prescriptions were 84% overall, and in similar proportions between the two groups. (4) Conclusions: in this small sample, antivirals seemed safe and showed no differences in efficacy as compared to MAbs for the early treatment of COVID-19 in fragile children, thus representing a valuable choice, even when administered off-label.

Details

Language :
English
ISSN :
19994915
Volume :
15
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Viruses
Publication Type :
Academic Journal
Accession number :
edsdoj.6c11e3ca757443982217b310de15c41
Document Type :
article
Full Text :
https://doi.org/10.3390/v15010192