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

FLU 003 Plus（呼吸道病毒住院研究，INSIGHT方案编号003）于2009年9月作为H1N1 v住院研究（FLU 003）启动。最初的目的是连续入组在2009年H1N1流感病毒大流行在其地理区域广泛传播时因并发症或严重疾病住院的当地诊断为甲型流感的个体，并在入组后60天内随访其临床病程。2011年6月，对方案进行了修订，纳入了诊断为流感（确诊或疑似）的患者，无论类型或亚型如何，因并发症或严重疾病住院。2013年8月，该方案进一步扩展，纳入了疑似或确诊为靶向非流感病毒性呼吸道感染的受试者，例如，MERS-CoV，以及确诊或疑似流感（任何类型）。 正在利用FLU 003 Plus的现有基础设施和资源，以纳入SARS-CoV-2感染者。本报告介绍了为将COVID-19参与者纳入观察性呼吸道病毒住院研究而做出的增量努力。 截至2020年8月中旬，450名新冠肺炎患者参与了观察性研究，以估计SARS-CoV-2感染参与者的发病率和死亡率，并检查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.