International Observational Study to Characterize Adults Hospitalized with Complications of influenza Hospitalization Study (FLU 003 Plus) Portion of Study Expanded to Include COVID-19 Patients

描述因流感并发症而住院的成人特征的国际观察性研究（FLU 003 Plus）研究部分扩大到包括 COVID-19 患者

• 批准号: 10283890
• 负责人: Richard Davey
• 金额: $ 348.72万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10283890
• 关键词: 2019-nCoV; Address; Adult; China; Clinical; Clinical Research; Coronavirus; Diagnosis; Disease; Enrollment; Geographic Locations; Hospitalization; Individual; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Influenza A virus; Influenza B Virus; Infrastructure; International; Middle East Respiratory Syndrome Coronavirus; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Observational Study; Participant; Patients; Protocols documentation; Public Health; Reporting; Resources; SARS coronavirus; Severities; Time; Viral Respiratory Tract Infection; Virus Diseases; coronavirus disease; influenzavirus; mortality; novel; pandemic disease; respiratory virus; seasonal influenza

The FLU 003 Plus (Respiratory Virus Hospitalization Study, INSIGHT Protocol No. 003) opened in September 2009 as the H1N1v Hospitalization Study (FLU 003). The initial purpose was to consecutively enroll individuals locally diagnosed with influenza A who were hospitalized with complications or severe disease at times when the pandemic 2009 H1N1 influenza virus was broadly circulating in their geographic area and to follow their clinical course over 60 days following enrollment. In June 2011 the protocol was amended to include enrollment of patients with a diagnosis of influenza (confirmed or suspected), irrespective of type or subtype, who are hospitalized with complications or severe disease. In August 2013, the protocol was further expanded to include participants with a suspected or confirmed diagnosis of a targeted non-influenza viral respiratory infection, e.g., MERS-CoV, in addition to confirmed or suspected influenza (of any type). The existing infrastructure and resources for FLU 003 Plus are being leveraged to include participants who are SARS-CoV-2 infected. This report addresses the incremental efforts to enroll COVID-19 participants into the observational Respiratory Virus Hospitalization Study. As of mid-August 2020, 450 COVID patients had been enrolled in the observational study to estimate rates of morbidity and mortality and to examine predictors of severity among participants with SARS-CoV-2 infection.

FLU 003 Plus（呼吸道病毒住院研究，Insight方案号003）于2009年9月作为H1N1V住院研究（FLU 003）开放。最初的目的是在当地诊断出患有流感的人，他们有时在2009 H1N1流感病毒的地理区域广泛循环，并在入学后60天内遵循其临床过程。 2011年6月，该方案被修改为包括诊断为流感诊断（确认或怀疑）的患者，无论类型或亚型，他们都患有并发症或严重疾病。 2013年8月，该方案进一步扩展到包括对靶向非炎性病毒呼吸道感染（例如MERS-COV）的疑似或确认诊断的参与者，此外还包括确认或怀疑的流感（任何类型）。 Flu 003 Plus的现有基础架构和资源正在利用，其中包括被SARS-COV-2感染的参与者。该报告介绍了将COVID-19参与者纳入观察性呼吸道病毒住院研究的增量努力。 截至2020年8月中旬，已经参加了450名Covid患者，以估计发病率和死亡率的率，并检查SARS-COV-2感染参与者的严重程度的预测因素。

项目成果

Understanding the treatment benefit of hyperimmune anti-influenza intravenous immunoglobulin (Flu-IVIG) for severe human influenza.

• DOI: 10.1172/jci.insight.167464
• 发表时间: 2023-07-24
• 期刊: JCI INSIGHT
• 影响因子: 8
• 作者: Vanderven, Hillary A.;Wentworth, Deborah N.;Han, Win Min;Peck, Heidi;Barr, Ian G.;Davey, Jr Richard T.;Beigel, John H.;Dwyer, Dominic E.;Jain, Mamta K.;Angus, Brian;Brandt, Christian T.;Mykietiuk, Analia;Law, Matthew G.;Neaton, James D.;Kent, Stephen J.
• 通讯作者: Kent, Stephen J.