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

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.

SUBMITTER: Minotti C

PROVIDER: S-EPMC9867507 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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

Minotti Chiara C Mengato Daniele D De Pieri Marica M Trivellato Sabrina S Francavilla Andrea A Di Chiara Costanza C Liberati Cecilia C Mattera Raffaele R Biffi Alessandra A Giaquinto Carlo C Venturini Francesca F Donà Daniele D

Viruses 20230110 1

(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, obs ...[more]

PMID: 36680232

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Project description:IntroductionThe COVID-19 pandemic has resulted in numerous deaths, great suffering, and significant changes in people's lives worldwide. The introduction of the vaccines was a light in the darkness, but after 18 months, a great disparity in vaccination coverage between countries has been observed. As disparities in vaccination coverage have become a global public health issue, this study aimed to analyze several variables to identify possible determinants of COVID-19 vaccination.MethodsAn ecological study was conducted using pooled secondary data sourced from institutional sites. A total of 205 countries and territories worldwide were included. A total of 16 variables from different fields were considered to establish possible determinants of COVID-19 vaccination: sociodemographic, cultural, infrastructural, economic and political variables, and health system performance indicators. The percentage of the population vaccinated with at least one dose and the total doses administered per 100 residents on 15 June 2022 were identified as indicators of vaccine coverage and outcomes. Raw and adjusted values for delivered vaccine doses in the multivariate GLM were determined using R. The tested hypothesis (i.e., variables as determinants of COVID-19 vaccination) was formulated before data collection. The study protocol was registered with the grant number NCT05471635.ResultsGDP per capita [odds = 1.401 (1.299-1.511) CI 95%], access to electricity [odds = 1.625 (1.559-1.694) CI 95%], political stability, absence of violence/terrorism [odds = 1.334 (1.284-1.387) CI 95%], and civil liberties [odds = 0.888 (0.863-0.914) CI 95%] were strong determinants of COVID-19 vaccination. Several other variables displayed a statistically significant association with outcomes, although the associations were stronger for total doses administered per 100 residents. There was a substantial overlap between raw outcomes and their adjusted counterparts.DiscussionThis pioneering study is the first to analyze the association between several different categories of indicators and COVID-19 vaccination coverage in a wide complex setting, identifying strong determinants of vaccination coverage. Political decision-makers should consider these findings when organizing mass vaccination campaigns in a pandemic context to reduce inequalities between nations and to achieve a common good from a public health perspective.

Dataset Information

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

Publications

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

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