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

流感003 Plus(呼吸道病毒住院研究，洞察议定书，第003号)于2009年9月作为H1N1v住院研究(流感003)开始。最初的目的是连续招募当地确诊为甲型流感的患者，这些患者在2009年H1N1流感大流行期间因并发症或严重疾病住院治疗，并在注册后60天内跟踪他们的临床过程。2011年6月，对议定书进行了修订，纳入了确诊为流感(确诊或疑似)的患者，无论其类型或亚型如何，他们都因并发症或严重疾病而住院。2013年8月，该议定书进一步扩大，除确诊或疑似流感(任何类型)外，还包括疑似或确诊为目标性非流感病毒呼吸道感染(如MERS-CoV)的参与者。 流感003 Plus的现有基础设施和资源正在被利用，以包括感染SARS-CoV-2的参与者。本报告介绍了将新冠肺炎参与者纳入观察性呼吸道病毒住院研究的渐进努力。 截至2020年8月中旬，450名COVID患者参加了这项观察性研究，以估计发病率和死亡率，并检查感染SARS-CoV-2的参与者中严重程度的预测因素。

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.