NCT02108366

Treatment of Severe Influenza A Infection

A Randomized Controlled Trial on the Treatment of Severe Influenza A Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	Celecoxib	Celecoxib 200mg daily
DRUG	Oseltamivir	Oseltamivir 75mg bid
DRUG	Placebo	Placebo capsule identical in appearance to celecoxib capsule, containing corn starch

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-03-01
• Completion: 2018-06-01
• First posted: 2014-04-09
• Last updated: 2019-10-21

Locations

1 site across 1 country: Hong Kong