Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial in hibernation, ready for rapid activation

Lim WS, Brittain C, Duley L, Edwards S, Gordon S, Montgomery A, Nguyen-Van-Tam J, Read R, Whitham D, Whynes D, Woodhead M, Wootton D
Record ID 32015000313
English
Authors' objectives: To (1) evaluate whether or not low-dose corticosteroids given as an adjunct to standard treatment is beneficial in patients who are hospitalised with severe pandemic influenza and (2) develop an 'off-the-shelf' clinical trial that is ready to be activated in a future pandemic.
Authors' recommendations: This study demonstrates that advance set-up of a trial to be conducted during a pandemic, with full regulatory approvals in place, is possible. Regular review during the hibernation phase will be required. This study serves as a model for the development of other 'off-the-shelf' trials as part of preparedness planning for public health emergencies.
Details
Project Status: Completed
Year Published: 2015
URL for published report: http://www.journalslibrary.nihr.ac.uk/hta/hta19160/#/abstract
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Double-Blind Method
  • Drug Therapy, Combination
  • Pandemics
  • Research Design
  • Dexamethasone
  • Glucocorticoids
  • Influenza, Human
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.