Dexsol (Dexamethasone) 2mg/5ml Oral Solution manufactured by Rosemont Pharmaceuticals Ltd (PL 00427/0137) will be used in this trial. Rosemont will also manufacture a matching placebo formulation.
Dexamethasone 6 mg as a liquid solution (15ml) once daily for 5 days, administered orally or via enteral feeding tube.
Matched placebo solution (15ml) once daily for 5 days, administered orally or via enteral feeding tube.
Participants will receive 15ml dexamethasone (6 mg) or placebo as a liquid solution once daily for 5 days, administered orally or via a nasogastric feeding tube.
All other care will be according to national clinical management guidelines for pandemic influenza.
First dose of IMP
The first dose of IMP should be given as soon as possible after consent for trial participation has been obtained, regardless of the time of day.
Subsequent doses of IMP
The date when the first dose of IMP is given to the trial participant should be considered as Day 1 of IMP treatment regardless of the time the dose was given. The second dose of IMP should not be given until the following day (Day 2), preferably in the morning. Further doses should ideally be given each morning.
Please note that this means for any patient receiving their first dose of IMP in the early hours of the morning (Day 1), the dose interval between first and second dose will be more than 24 hours. For those patients randomised late evening, the second dose will be given the following.
Packaging and labelling
Rosemont will ship bulk supply of dexamethasone and placebo to one or more manufacturing units, who will be set up to provide the randomised final labelling, packaging and release service in order to ensure the short timeline from activation to the start of trial recruitment is met.
The manufacturing units will receive bulk active and placebo bottles from Rosemont. They will over-label a single 75ml bottle according to Annex 13 and pack with written instructions in a clear outer pack so that the primary packaging label can be read through the pack.
The final product will be QP released by the designated person at the manufacturing unit.
An outer dispenser pack will be assembled containing, in number order the finished active and placebo packs. This will allow the trial treatment packs to be removed from the dispenser in sequence order.
The manufacturing unit where the packaging and release occurs will distribute trial supplies to participating sites.This page was last updated on May 13th, 2015 at 1:53 pm