Trial Name: Double-blinded randomised trial of early low dose steroids in patients admitted to hospital with influenza infection during a pandemic (ASAP)
Chief Investigator: Wei Shen Lim, Nottingham University Hospitals NHS Trust
Trial Description: An influenza pandemic occurs when a new strain of influenza virus emerges which is different from other currently circulating strains of the virus. This means that few people have any protection against the new virus, and so the virus can infect people easily. The virus therefore spreads on a worldwide scale and infects a large proportion of the population. In contrast to the regular seasonal epidemics of influenza, these pandemics occur irregularly, with the 1918 Spanish flu the most serious pandemic in recent history. There are currently no markers that will predict the pathogenicity or spread of a potential pandemic strain. Therefore, any plans for a future pandemic need to be flexible and take account of different possible senarios from mild to severe.
Corticosteroid use in influenza is widespread, non-systematic and controversial. During the last pandemic in 2009, corticosteroid use during hospital admission was reported in various cohort studies and non-randomised studies but there are no randomised trials of the use of corticosteriods for patients with pandemic, avian or seasonal influenza infection.
This trial will assess the effects of adding a five-day course of dexamethasone (a corticosteroid), started within 24 hours of hospital admission, to standard care. Participants will be adults hospitalised with an influenza-like illness during the pandemic. Estimated sample size is 2,200 participants. The primary outcome is admission to intensive care unit or death, within 30 days of hospital admission. During a pandemic, the aim is to activate the trial within four weeks during the first wave of the pandemic, and to complete recruitment in six weeks. Results would then inform clinical practice and health policy during the second wave.
The trial is now set up, with full regulatory approval, and has been hibernated. During hibernation the trial will be reviewed annually to ensure it remains read to activate rapidly when required.
Contact: Garry Meakin
Funding: NIHR Health Technology Assessment
Publications: 2013-20; 2015-7; 2015-53, 2017-18, 2019-5
Further Information: Garry Meakin (Trial Manager) firstname.lastname@example.org