search
Back to results

Treatment of Severe Influenza A Infection

Primary Purpose

Influenza, Human

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Celecoxib
Oseltamivir
Placebo
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza, Human focused on measuring severe, influenza A, celecoxib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) Male or female patients ≥18 years 2) Written informed consent by patient or next-of kin (if patient is too ill to consent) 3) Presumptive diagnosis of influenza A satisfying both clinical and laboratory criteria. The laboratory criteria are defined as at least one RT-PCR positive for influenza A (H1N1, H3N2, H5N1 and H7N9) from respiratory clinical specimens including nasopharyngeal samples and endotracheal aspirates. The clinical criteria are defined as hospitalization with fever or one of the symptoms suggestive of influenza infection including sore throat, rhinorrhea, cough or shortness of breath 2) Desaturation to <90% in room air by pulse oximetry and required oxygen supplement 3) Within 7 days of onset of symptoms. Patients have to fulfil all the aforementioned criteria.

Exclusion Criteria:

1) Age <18 years. 2) A known hypersensitivity to celecoxib, oseltamivir or zanamivir 3) Unable to obtain informed consents 4) Influenza A infection diagnosed beyond 7 days from symptom onset 5) Patients receiving other antiviral treatment (apart from oseltamivir or zanamivir), N-acetylcystiene, statins and tradition Chinese medicine during the current admission 6) Patients with renal impairment of creatinine clearance < 30mL/min

Sites / Locations

  • Ivan Hung

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Celecoxib

Arm Description

Placebo + oseltamivir 75mg bid for 5 days

Celecoxib 200mg daily + oseltamivir 75mg bid for 5 days

Outcomes

Primary Outcome Measures

Mortality rate
28 days mortality from hospitalization

Secondary Outcome Measures

Viral load
1 day before treatment for 1 week
Cytokine
1 day before treatment for 7 days
Intensive care stay
Period under intensive care
Ventilatory support period
Duration of patient on ventilatory support
Systemic adverse events
from commencement of treatment for 1 week
Hospitalization
from hospital admission to discharge

Full Information

First Posted
March 31, 2014
Last Updated
October 18, 2019
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT02108366
Brief Title
Treatment of Severe Influenza A Infection
Official Title
A Randomized Controlled Trial on the Treatment of Severe Influenza A Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
severe, influenza A, celecoxib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + oseltamivir 75mg bid for 5 days
Arm Title
Celecoxib
Arm Type
Experimental
Arm Description
Celecoxib 200mg daily + oseltamivir 75mg bid for 5 days
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
COX II inhibitor
Intervention Description
Celecoxib 200mg daily
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
Oseltamivir 75mg bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Corn starch
Intervention Description
Placebo capsule identical in appearance to celecoxib capsule, containing corn starch
Primary Outcome Measure Information:
Title
Mortality rate
Description
28 days mortality from hospitalization
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Viral load
Description
1 day before treatment for 1 week
Time Frame
7 days
Title
Cytokine
Description
1 day before treatment for 7 days
Time Frame
7 days
Title
Intensive care stay
Description
Period under intensive care
Time Frame
An expected average of 2 weeks
Title
Ventilatory support period
Description
Duration of patient on ventilatory support
Time Frame
An expected average of 2 weeks
Title
Systemic adverse events
Description
from commencement of treatment for 1 week
Time Frame
1 week
Title
Hospitalization
Description
from hospital admission to discharge
Time Frame
An expected average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Male or female patients ≥18 years 2) Written informed consent by patient or next-of kin (if patient is too ill to consent) 3) Presumptive diagnosis of influenza A satisfying both clinical and laboratory criteria. The laboratory criteria are defined as at least one RT-PCR positive for influenza A (H1N1, H3N2, H5N1 and H7N9) from respiratory clinical specimens including nasopharyngeal samples and endotracheal aspirates. The clinical criteria are defined as hospitalization with fever or one of the symptoms suggestive of influenza infection including sore throat, rhinorrhea, cough or shortness of breath 2) Desaturation to <90% in room air by pulse oximetry and required oxygen supplement 3) Within 7 days of onset of symptoms. Patients have to fulfil all the aforementioned criteria. Exclusion Criteria: 1) Age <18 years. 2) A known hypersensitivity to celecoxib, oseltamivir or zanamivir 3) Unable to obtain informed consents 4) Influenza A infection diagnosed beyond 7 days from symptom onset 5) Patients receiving other antiviral treatment (apart from oseltamivir or zanamivir), N-acetylcystiene, statins and tradition Chinese medicine during the current admission 6) Patients with renal impairment of creatinine clearance < 30mL/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan FN HUNG, MD FRCP
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ivan Hung
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Treatment of Severe Influenza A Infection

We'll reach out to this number within 24 hrs