Children represent a minority of total COVID-19 cases, but studies have reported severe disease and death in pediatric patients. Remdesivir (RDV) has recently demonstrated promising results in adults with COVID-19, but few data have been reported to date in children.
A nationwide multicenter observational study was conducted on children with confirmed SARS-CoV-2 receiving compassionate treatment with RDV in Spain. Eight patients were included in the study, four infants and four older children [median age 5 years old; IQR 4 months–11.6 years old]. Half of them had complex underlying medical conditions, and the rest were mostly infants (3/4). Six out of eight children needed Pediatric Intensive Care Unit Admission. No RDV-related adverse outcomes were observed in our patients. Seven have reached successful clinical outcome, but one patient with serious clinical status died due to complications. However, she received RDV very late after the first COVID-19 symptom.
Conclusions
: In our cohort, most of the patients achieved successful clinical outcome, without observing adverse events. Clinical trials of RDV therapy for children with COVID-19 are urgently needed, to assess the safety, tolerability, efficacy, and pharmacokinetics of RDV in children, as this could be an effective treatment in severe cases.
What is Known:
• Remdesivir has not been approved to treat COVID-19 in children under 12 years old, although the drug is currently being prescribed in critically ill children.
• Remdesivir has recently demonstrated promising results in adults with COVID-19, but few data have been reported to date in paediatric population.
What is New:
• We report a multicentre cohort of children with confirmed SARS-CoV-2 and severe COVID-19 disease receiving remdesivir during the first month of the pandemic in Spain.
• No remdesivir-related adverse outcomes were observed in most of the cases. Seven patients reached successful clinical outcome, and one died due to complications (bacterial sepsis).
Supplementary Information
The online version contains supplementary material available at 10.1007/s00431-020-03876-1.
The standard rapid approach for the diagnosis of coronavirus disease 2019 (COVID-19) is the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA. The detection of specific anti-SARS-CoV-2 immunoglobulins is crucial for screening people who have been exposed to the virus, whether or not they presented symptoms. Recent publications report different methods for the detection of specific IgGs, IgMs, and IgAs against SARS-CoV-2; these methods mainly detect immunoglobulins in the serum using conventional techniques such as rapid lateral flow tests or enzyme-linked immunosorbent assay (ELISA). In this article, we report the production of recombinant SARS-CoV-2 spike protein and the development of a rapid, reliable, cost-effective test, capable of detecting immunoglobulins in serum and saliva samples. This method is based on interferometric optical detection. The results obtained using this method and those obtained using ELISA were compared. Owing to its low cost and simplicity, this test can be used periodically for the early detection, surveillance, detection of immunity, and control of the spread of COVID-19.
Despite the remarkable development related to Point-of-Care devices based on optical technology, their difficulties when used outside of research laboratories are notable. In this sense, it would be interesting to ask ourselves what the degree of transferability of the research work to the market is, for example, by analysing the relation between the scientific work developed and the registered one, through patent. In this work, we provide an overview of the state-of-the-art in the sector of optical Point-of-Care devices, not only in the research area but also regarding their transfer to market. To this end, we explored a methodology for searching articles and patents to obtain an indicator that relates to both. This figure of merit to estimate this transfer is based on classifying the relevant research articles in the area and the patents that have been generated from these ones. To delimit the scope of this study, we researched the results of a large enough number of publications in the period from 2015 to 2020, by using keywords “biosensor”, “optic”, and “device” to obtain the most representative articles from Web of Science and Scopus. Then, we classified them according to a particular classification of the optical PoC devices. Once we had this sampling frame, we defined a patent search strategy to cross-link the article with a registered patent (by surfing Google Patents) and classified them accordingly to the categories described. Finally, we proposed a relative figure called Index of Technology Transference (IoTT), which estimates to what extent our findings in science materialized in published articles are protected by patent.
In the present work, highly multiplexed diagnostic KITs based on an Interferometric Optical Detection Method (IODM) were developed to evaluate six Coronavirus Disease 2019 (COVID-19)-related biomarkers. These biomarkers of COVID-19 were evaluated in 74 serum samples from severe, moderate, and mild patients with positive polymerase chain reaction (PCR), collected at the end of March 2020 in the Hospital Clínico San Carlos, in Madrid (Spain). The developed multiplexed diagnostic KITs were biofunctionalized to simultaneously measure different types of specific biomarkers involved in COVID-19. Thus, the serum samples were investigated by measuring the total specific Immunoglobulins (sIgT), specific Immunoglobulins G (sIgG), specific Immunoglobulins M (sIgM), specific Immunoglobulins A (sIgA), all of them against SARS-CoV-2, together with two biomarkers involved in inflammatory disorders, Ferritin (FER) and C Reactive Protein (CRP). To assess the results, a Multiple Linear Regression Model (MLRM) was carried out to study the influence of IgGs, IgMs, IgAs, FER, and CRP against the total sIgTs in these serum samples with a goodness of fit of 73.01% (Adjusted R-Squared).
BackgroundHepatic veno-occlusive (VOD) disease is a potentially life threatening complication that mainly occurs after myeloablative conditioning therapy and haematopoietic stem cell transplantation (HSCT). The disease is characterised by increased serum bilirubin concentrations, tender hepatomegaly, fluid retention and weight gain. Severe VOD is one of the most frequent causes of early death in the HSCT setting, with a mortality rate of up to 98% by day +100 post-HSCT. There are few effective options that target the underlying cause. Defibrotide has recently been authorised via the centralised procedure of the EMA for the treatment of severe VOD in adults and children, as it has been associated with complete response (CR) rates of 36–76%, and by 100 days post-HSCT survival rates of 32–79% in clinical trials.PurposeTo determine the CR rate in patients with severe VOD following HSCT treated with defibrotide, and survival rates by 100 days post-HSCT.Material and methodsA retrospective observational study. Adults or children with VOD treated with defibrotide were included. CR was defined as normalisation of total serum bilirubin levels and resolution of multiple organ failure (renal, pulmonary and central nervous system). A secondary endpoint was survival by 100 days post- HSCT.Results42 patients (30 adults and 12 children) with VOD received defibrotide. Mean age was 46 (range 19–70) years for adults and 7 (range 0.25–16) years for children. Patients received their first dose at a median of 18 (range 3–56) days after myeloablative conditioning therapy. The mean dose of defibrotide was 25 (range 10–45) mg/kg/day and the median duration of therapy was 11 (range 1–40) days.After treatment with defibrotide, CR was found in 13 patients (30.95%). By 100 days post-HSCT, CR in the evaluable population was achieved in 12 patients (28.57%) and the survival rate was 50%; 21 patients were still alive with resolution of VOD.ConclusionDefibrotide has demonstrated a limited effectiveness in our study and other published studies. We have to consider that VOD is a rare disorder, and as a result the first limitation of studies is the small number of patients that can be included. Consequently, more effectiveness studies with more patients are needed.References and/or AcknowledgementsHospital La PazNo conflict of interest.
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