Treatment of Severe Influenza A Infection

NCT02108366 | Completed Phase 3 DMC

• 1 other identifier: UW 13-009
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Keywords

severe; influenza A; celecoxib

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  28 days mortality from hospitalization

  28 days

Secondary Outcomes (6)

• Viral load

  7 days

• Cytokine

  7 days

• Intensive care stay

  An expected average of 2 weeks

• Ventilatory support period

  An expected average of 2 weeks

• Systemic adverse events

  1 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo + oseltamivir 75mg bid for 5 days

Drug: Oseltamivir; Drug: Placebo

Celecoxib

EXPERIMENTAL

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

Drug: Celecoxib; Drug: Oseltamivir

Interventions

Celecoxib DRUG

Celecoxib 200mg daily

Also known as: COX II inhibitor

Celecoxib

Oseltamivir DRUG

Oseltamivir 75mg bid

Also known as: Tamiflu

Celecoxib; Placebo

Placebo DRUG

Placebo capsule identical in appearance to celecoxib capsule, containing corn starch

Also known as: Corn starch

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Ivan Hung

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Influenza, Human; Lymphoma, Follicular

Interventions

Celecoxib; Oseltamivir; Starch

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetamides; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Ivan FN HUNG, MD FRCP

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 9, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

HK (1)