Influenza Studies

In response to the 2009 H1N1 influenza pandemic, INSIGHT expanded its research focus into influenza, undertaking two international observational studies on the influenza virus: FLU 002 Plus (Respiratory Virus Outpatient Study, INSIGHT Protocol No. 002) and FLU 003 Plus (Respiratory Virus Hospitalization Study, INSIGHT Protocol No. 003). A synopsis of each protocol, as well as links to several summary reports (enrollment numbers, patient characteristics at enrollment, central laboratory results, and patient outcomes) can be found in the table below. In June 2011 the protocols were expanded to encompass types of influenza other than H1N1, and in August 2013 the protocol was further expanded to include enrollment of participants with a suspected targeted non-influenza respiratory virus, e.g., MERS-CoV, in addition to those with suspected influenza. The list of targeted non-influenza respiratory viruses can be found here.

In late 2013, INSIGHT opened a pilot study (FLU-IVIG Pilot, INSIGHT Protocol No. 005) of using intravenous anti-influenza hyperimmune globulin (IVIG) to treat individuals with confirmed influenza (A-H1N1, A-H3N2, or B) to see if IVIG in addition to standard anti-influenza drugs would be beneficial. The pilot was successful in demonstrating an adequate immunological response to IVIG, and a clinical efficacy study,FLU-IVIG (INSIGHT Protocol No. 006), is opening in late 2014 -- early 2015 in the US and Europe, with expansion planned to countries in the Southern Hemisphere in mid-2015. A link to the synopsis of each protocol and to summary reports are in the table below.