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临床试验/NCT05071690
NCT05071690Unknown不适用

COVID-19: Why Are Children Less Affected

Ministry of Health, Saudi Arabia2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2021年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
measurement of percentage of plasma DHA at two groups of infants and children's

研究概览

简要总结

Observational Study of Infants Fed on DHA (Breast Source or Milk Formula Source ) and Its Effect on COVID-19 Severity

Abstract

The novel SARS-CoV-2, which causes the disease called COVID-19, has rapidly spread across the globe. A striking and consistent observation has been the difference in severity of COVID-19 at different ages: severity, the need for hospitalization and mortality rise steeply with older age while severe disease and death are relatively rare in children and young adults. Most infants and children infected with SARS-CoV-2 are asymptomatic or have mild symptoms, most commonly fever, cough, pharyngitis, gastrointestinal symptoms and changes in sense of smell or taste. Whether infants and children are also less often infected by SARS-CoV-2 is an ongoing debate. Large epidemiological studies suggest that infants and children comprise only 1 to 2% of all SARS-CoV-2 cases. However, these numbers heavily depend on testing criteria and, in many reports, testing was done only in individuals who were symptomatic or required hospitalization, which is less often the case for children. Some studies suggest that infants and children are just as likely as adults to become infected with SARS-CoV-2.9 However, more recent studies report that children are less likely to get infected after contact with a SARS-CoV-2-positive individual.10-14 It has been suggested that children and adolescents have similar viral loads and may therefore be as likely to transmit SARS-CoV-2 as adults. In addition, the viral load may be similar in asymptomatic and symptomatic individuals. However, reassuringly, transmission in schools from children either to other children or to adults has been rare. The observation that children are less often infected with SARS-CoV-2 and that they have less severe symptoms is similar to that reported for SARS-CoV-1 and Middle East respiratory syndrome (MERS)-CoV. However, this pattern is strikingly different to that for infection with most other respiratory viruses (eg, respiratory syncytial virus (RSV), metapneumovirus, parainfluenza or influenza viruses), for which the prevalence and severity are both higher in children.Dr Amr kamel khalil Ahmed and Dr. Mahmoud Elkazzaz, the lead investigators of this observational study , recently published a preprint that demonstrated Docosahexaenoic acid (DHA) had a high binding affinity and greatest interactions with ACE2 active sites, as well as a moderate binding affinity and moderate interactions with the active sites of IL-6. The Docosahexaenoic acid (DHA) interacts with different active sites of IL6 and ACE2 which are involved in direct or indirect contacts with the ACE2 and IL-6 receptors which might act as potential blockers of functional ACE2 and IL-6 receptor complex. Docosahexaenoic acid (DHA) was detected in abundance in breast milk and other algal sources milk supplement used for newborns and children's feeding. As a result, we believe that docosahexaenoic acid (DHA) may protect children and newborns thorough competing with COVID-19 for ACE2 receptors and inhibiting IL-6 activity and may possibly help them avoid a cytokine storm and save their lives through inhibiting IL-6 and preventing SARS-CoV-2 RBD attachment to ACE2

详细描述

the study observational study case control study two groups of infants and children on DHA supplement A arm group on breast milk and measure the DHA level and determine the degree of severity of covid-19 symptoms according the classification of CDC the B arm infants on DHA at milk formula or DHA supplement and measure the DHA level and determine the severity of covid-19 according the classification of CDC

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • full term baby infants and children until 5 years breast feeding or milk formula or supplement on DHA

排除标准

  • above 5 years no congenital diseases outside kingdom saudia arabia preterm

结局指标

主要结局

measurement of percentage of plasma DHA at two groups of infants and children's

时间窗: 6 month

plasma DHA is very important to be measured

the severity of COVID-19 symptoms at infants and children on DHA at milk formula and on breast feeding

时间窗: 6 month

comparison between two control groups infants and children on breast milk and group on milk formula nouriched at DHA

次要结局

  • THE duration of symptoms at two groups(6 month)

研究者

发起方
Ministry of Health, Saudi Arabia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amr kamel khalil Ahmed

Clinical Scientist

Ministry of Health, Saudi Arabia

研究点 (2)

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