A Single-center Experience in Treating Young Children at High Risk For Severe COVID-19 With Sotrovimab

Pruccoli, Giulia; Bertorello, Nicoletta; Mignone, F; Silvestro, Erika; Scolfaro, Carlo; Garazzino, Silvia

doi:10.1097/inf.0000000000003552

Cited by 5 publications

(2 citation statements)

References 5 publications

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“…Forty‐seven of these articles were not in English or not dealing with safety concerns. One article was considered for further evaluation (Pruccoli et al., ). The paper described a case of bacteraemia in a 5‐month child with a diagnosis of heart disease.…”

Section: Assessmentmentioning

confidence: 99%

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020

Koutsoumanis¹,

Allende²,

Álvarez‐Ordóñez³

et al. 2020

EFS2

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The qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels. It is based on an assessment of the taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by ‘qualifications’. No new information was found that would change the previously recommended QPS TUs of the 39 microorganisms notified to EFSA between October 2019 and March 2020, 33 were excluded, including five filamentous fungi, five Escherichia coli, two Enterococcus faecium, two Streptomyces spp. and 19 TUs already evaluated. Six TUs were evaluated. Akkermansia muciniphila was not recommended for QPS status due to safety concerns. Clostridium butyricum was not recommended because some strains contain pathogenicity factors. This TU was excluded for further QPS evaluation. Galdieria sulphuraria and Pseudomonas chlororaphis were also rejected due to a lack of body of knowledge. The QPS status of Corynebacterium ammoniagenes (with the qualification ‘for production purposes only’) and of Komagataella pastoris (with the qualification ‘for enzyme production’) was confirmed. In relation to the taxonomic revision of the Lactobacillus genus, previously designated Lactobacillus species will be reassigned to the new species and both the old and new names will be retained in the QPS list.

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Section: Assessmentmentioning

confidence: 99%

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020

Koutsoumanis¹,

Allende²,

Álvarez‐Ordóñez³

et al. 2020

EFS2

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“…Its neutralizing activity against the widespread Omicron BA.2 subvariant was then proved to be reduced, so it is no longer recommended where this variant is dominant. Among recent evidence, there is a case series of 5 children younger than 12 years old safely receiving sotrovimab for a high risk of progression to severe COVID-19 [ 24 ]. Despite the fact the sample was smaller than the one in this study, sotrovimab administration was similarly safe.…”

Section: Discussionmentioning

confidence: 99%

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

Minotti

Mengato

Pieri

et al. 2023

Viruses

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(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.

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Safety of Sotrovimab use in children with COVID-19: an Italian experience

Venturini,

Fusani,

Lo Vecchio

et al. 2023

Journal of Chemotherapy

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A Single-center Experience in Treating Young Children at High Risk For Severe COVID-19 With Sotrovimab

Cited by 5 publications

References 5 publications

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 12: suitability of taxonomic units notified to EFSA until March 2020

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

Safety of Sotrovimab use in children with COVID-19: an Italian experience

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