Early Treatments of Fragile Children with COVID-19—Results of CLEVER (Children COVID Early Treatment), a Retrospective, Observational Study
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
Affiliations
Chiara Minotti
Division of Pediatric Infectious Diseases, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
Daniele Mengato
Hospital Pharmacy Department, University Hospital of Padua, Via Giustiniani, 2, 35128 Padua, Italy
Marica De Pieri
Division of Pediatric Infectious Diseases, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
Sabrina Trivellato
Hospital Pharmacy Department, University Hospital of Padua, Via Giustiniani, 2, 35128 Padua, Italy
Andrea Francavilla
Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Loredan, 18, 35131 Padova, Italy
Costanza Di Chiara
Division of Pediatric Infectious Diseases, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
Cecilia Liberati
Division of Pediatric Infectious Diseases, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
Raffaele Mattera
Division of Pediatric Hematology, Oncology and Stem Cell Transplant, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
Alessandra Biffi
Division of Pediatric Hematology, Oncology and Stem Cell Transplant, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
Carlo Giaquinto
Division of Pediatric Infectious Diseases, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
Francesca Venturini
Hospital Pharmacy Department, University Hospital of Padua, Via Giustiniani, 2, 35128 Padua, Italy
Daniele Donà
Division of Pediatric Infectious Diseases, Department of Women’s and Children’s Health, University of Padua, Via Giustiniani, 3, 35128 Padua, Italy
(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.
