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

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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.