Each year, influenza A infection caused great mortality and morbidity, especially among the elderly and individuals with chronic illness. Many of these patients are 'late presenters' who are admitted to hospital a few days after symptoms onset and have developed complications secondary to immunodysregulation. Antiviral treatment with the neuraminidase inhibitor is of limited usage for patients who presented to the hospital 48 hours after symptom onset. Apart from ventilatory and extracorporeal membrane oxygenation support, treatment options for these patients are limited. Recent animal study has demonstrated that combinations of an antiviral agent with a COX-II inhibitor can reduce mortality in mice infected with influenza virus. The investigators therefore propose to enrol patients with severe influenza A infection requiring hospitalization and oxygen support on a randomized controlled trial with celecoxib.
The aim of this double blind randomized controlled trial is to compare the clinical efficacy and safety of celecoxib combined with neuraminidase inhibitors in patients with severe influenza A infection. The hypothesis of this study is that treatment of severe influenza A infection with celecoxib will reduce mortality. The primary outcome to be assessed will be the 28-days mortality rate from hospitalization. The secondary outcomes to be assessed will be safety of the treatment, duration of intensive care, duration of ventilatory and oxygen support, the viral load and cytokine change.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
Celecoxib 200mg daily
Oseltamivir 75mg bid
Placebo capsule identical in appearance to celecoxib capsule, containing corn starch
Ivan Hung
Hong Kong, Hong Kong
Mortality rate
28 days mortality from hospitalization
Time frame: 28 days
Viral load
1 day before treatment for 1 week
Time frame: 7 days
Cytokine
1 day before treatment for 7 days
Time frame: 7 days
Intensive care stay
Period under intensive care
Time frame: An expected average of 2 weeks
Ventilatory support period
Duration of patient on ventilatory support
Time frame: An expected average of 2 weeks
Systemic adverse events
from commencement of treatment for 1 week
Time frame: 1 week
Hospitalization
from hospital admission to discharge
Time frame: An expected average of 4 weeks
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