A Phase 3 interventional study of Celecoxib and Oseltamivir in Influenza, Human, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by The University of Hong Kong · Phase 3, Interventional, and Treatment
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.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 107 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo + oseltamivir 75mg bid for 5 days
Drug: Oseltamivir · Drug: Placebo
Celecoxib 200mg daily + oseltamivir 75mg bid for 5 days
Drug: Celecoxib · Drug: Oseltamivir
Celecoxib 200mg daily
Also known as: COX II inhibitor
Oseltamivir 75mg bid
Also known as: Tamiflu
Placebo capsule identical in appearance to celecoxib capsule, containing corn starch
Also known as: Corn starch
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
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong