An International Observational Study to Characterize Adults Who Are Hospitalized with Complications of Influenza or Other Targeted Respiratory Viruses

Respiratory Virus Hospitalization Study (FLU 003 Plus)
(INSIGHT Protocol No. 003, version 3.0, dated 27 August 2013)

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity andmortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded. In 2020 the study protocol was expanded to include participants with SARS-CoV-2/COVID-19 infection.

For further details about the FLU 003 Plus study, please visit the INSIGHT website.