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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01231620




Registration number
NCT01231620
Ethics application status
Date submitted
28/10/2010
Date registered
1/11/2010
Date last updated
15/10/2018

Titles & IDs
Public title
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
Scientific title
A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza
Secondary ID [1] 0 0
114373
Universal Trial Number (UTN)
Trial acronym
ZORO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Human 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zanamivir
Treatment: Drugs - Placebo to match zanamivir
Treatment: Drugs - Oseltamivir
Treatment: Drugs - Placebo to match oseltamivir

Experimental: Intravenous (IV) Zanamivir 300mg Twice Daily - 300mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily

Experimental: Intravenous (IV) Zanamivir 600mg Twice Daily - 600mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily

Active Comparator: Oral Oseltamivir 75mg Twice Daily - 75mg oral oseltamivir twice daily plus intravenous placebo zanamivir twice daily


Treatment: Drugs: Zanamivir
Zanamivir aqueous solution, 10 mg/mL, will be provided as a single use, sterile clear, colorless preparation in 20 mL clear glass vials.

Treatment: Drugs: Placebo to match zanamivir
Placebo to match IV zanamivir will be provided as a normal saline solution of a matched volume.

Treatment: Drugs: Oseltamivir
Oseltamivir will be provided as over-encapsulated 75 mg capsules.

Treatment: Drugs: Placebo to match oseltamivir
Placebo to match oral oseltamivir will be provided as capsules with a common excipient of appropriate quality.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Clinical Response (TTCR) in Participants With Confirmed Influenza
Timepoint [1] 0 0
Up to 42 days
Secondary outcome [1] 0 0
Percentage of Participants With Respiratory Improvement
Timepoint [1] 0 0
Up to 42 days
Secondary outcome [2] 0 0
Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit
Timepoint [2] 0 0
On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days)
Secondary outcome [3] 0 0
Change From Baseline in the Katz Activities of Daily Living (ADL) Score and Each ADL Activity Score
Timepoint [3] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [4] 0 0
Median Time to Return to Pre-morbid Functional Status as Measured by the Katz ADL Score and Each ADL Activity Score
Timepoint [4] 0 0
Up to 42 days
Secondary outcome [5] 0 0
Number of Participants Who Returned to Their Pre-morbid Functional Status as Assessed Per the Katz ADL Score and Each ADL Activity Score at the End of the Study
Timepoint [5] 0 0
Up to 42 days
Secondary outcome [6] 0 0
Median Time to Return to the Pre-morbid Level of Activity as Measured by the 3-point Scale
Timepoint [6] 0 0
Up to 42 days
Secondary outcome [7] 0 0
Number of Participants With the Indicated Clinical Symptoms of Influenza
Timepoint [7] 0 0
Up to 42 days
Secondary outcome [8] 0 0
Median Time of Duration of Clinical Symptoms of Influenza
Timepoint [8] 0 0
Up to 42 days
Secondary outcome [9] 0 0
Number of Participants With Complications of Influenza and Associated Antibiotic Use
Timepoint [9] 0 0
Up to 42 days
Secondary outcome [10] 0 0
Number of Participants With the Indicated Ventilation Status: Modality of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation
Timepoint [10] 0 0
Up to 42 days
Secondary outcome [11] 0 0
Median Time of Duration of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation
Timepoint [11] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [12] 0 0
Median Time of Duration of Hospitalization and Intensive Care Unit (ICU) Stay
Timepoint [12] 0 0
Day 1 to the end of the study (assessed up to 42 days)
Secondary outcome [13] 0 0
Median Time to the Absence of Fever and Improved Respiratory Status, Oxygen Saturation, Heart Rate, and Systolic Blood Pressure
Timepoint [13] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [14] 0 0
Median Time to Virologic Improvement
Timepoint [14] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [15] 0 0
Change From Baseline in Quantitative Virus Culture From Nasopharyngeal Swabs Positive at Baseline
Timepoint [15] 0 0
Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable
Secondary outcome [16] 0 0
Change From Baseline Viral Load (Influenza A or B) by qPCR From Nasopharyngeal Swabs Positive at Baseline
Timepoint [16] 0 0
Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable
Secondary outcome [17] 0 0
Number of Participants With no Detectable Viral RNA and the Absence of Cultivable Virus in Lower Respiratory Samples (Bronchoalveolar Lavage Sample [BAL], Endotracheal Aspirate)
Timepoint [17] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [18] 0 0
Median Time to no Detectable Viral RNA and the Absence of Cultivable Virus in Any Obtained Sample (Upper and Lower Respiratory Samples)
Timepoint [18] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [19] 0 0
Number of Participants With Resistance-associated Mutations Detected in the Neuraminidase (NA) and Hemagglutinin (HA) Gene of Influenza A and B Viruses in Nasopharyngeal Swabs and Endotracheal/BAL Samples
Timepoint [19] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [20] 0 0
Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment
Timepoint [20] 0 0
Up to 42 days
Secondary outcome [21] 0 0
Number of Participants With Any Severe or Grade 3/4 AE
Timepoint [21] 0 0
Up to 42 days
Secondary outcome [22] 0 0
Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE
Timepoint [22] 0 0
Up to 42 days
Secondary outcome [23] 0 0
Number of Participants Who Were Permanently Discontinued From the Study Due to an AE
Timepoint [23] 0 0
Up to 42 days
Secondary outcome [24] 0 0
Number of Participants With Any Severe or Grade 3/4 Treatment-related AE
Timepoint [24] 0 0
Up to 42 days
Secondary outcome [25] 0 0
Number of Participants With the Indicated Chemistry Laboratory Values Shifts From Baseline (Day 1) and up to 42 Days
Timepoint [25] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [26] 0 0
Number of Participants With the Indicated Hematology Values Shifts From Baseline (Day 1) and up to 42 Days
Timepoint [26] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [27] 0 0
Number of Participants With the Indicated Treatment-emergent (TE) Grade (G) 3/4 Clinical Chemistry Toxicities
Timepoint [27] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [28] 0 0
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities
Timepoint [28] 0 0
Baseline (Day 1) and up to 42 days
Secondary outcome [29] 0 0
Median Quantity of Oxygen Delivery Measured at Baseline (Day 1) and During the Study
Timepoint [29] 0 0
Baseline (Day 1) and during the study
Secondary outcome [30] 0 0
Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) and Day 4
Timepoint [30] 0 0
Baseline (Day 1) and Day 4
Secondary outcome [31] 0 0
Serum Concentration of IV Zanamivir
Timepoint [31] 0 0
Day 1 and Day 4

Eligibility
Key inclusion criteria
- Male or female aged 16 years; a female is eligible to enter and participate in the
study if she is:

1. of non-childbearing potential (i.e., physiologically incapable of becoming
pregnant, including any female who is post- menopausal); or,

2. of child-bearing potential, has a negative pregnancy test at Baseline, and agrees
to use protocol specified methods of birth control while on study.

- Vital signs criteria defined as 3 or more of the following at Baseline:

1. Presence of fever [oral temperature of 38°C or equivalent] at Baseline. However,
this requirement is waived if the subject has a history of fever within in the 24
hours prior to Baseline; or, if the subject reported symptoms of feverishness at
some time during the 48 hours prior to Baseline.

AND at least 2 out of the following 4:

2. Oxygen saturation <95% on room air by trans-cutaneous method or need for any
supplemental oxygenation or ventilatory support, or increase in oxygen
supplementation requirement of =2 litres for subjects with chronic oxygen
dependency. For those subjects with a history of chronic hypoxia (without
supplemental oxygen), an oxygen saturation of at least 3% below the patient's
historical baseline oxygen saturation will satisfy this criterion.

3. Respiration rate >24 breaths per minute. For those subjects who require
ventilatory support or oxygen supplementation, this requirement is waived.

4. Heart rate >100 beats per minute.

5. Systolic blood pressure <90 mmHg.

- Onset of influenza symptoms within 6 days prior to study enrolment. Symptoms may
include cough, dyspnea, sore throat, feverishness, myalgias, headache, nasal symptoms
(rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea and vomiting.

- Clinical symptoms of influenza with positive influenza diagnostic test result or
strong suspicion of influenza illness based on clinical symptoms and local
surveillance information.

- Subjects willing and able to give written informed consent to participate in the study
and to adhere to the procedures stated in the protocol, or legally acceptable
representative willing and able to give written informed consent on behalf of the
subject for minors, unconscious adults and those incapable of consenting themselves
due to their medical condition, or included as permitted by local regulatory
authorities, IRB/IECs or local laws.

- Severity of any medical illness that, in the Investigator's judgement, justifies
hospitalization of the subject for treatment and supportive care

- French subjects: In France, a subject will be eligible for inclusion in this study
only if either affiliated to or a beneficiary of a social security category
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who have taken more than a total of 3 days (6 doses) of approved
anti-influenza therapy in the period from onset of symptoms and prior to enrolment.

- Subjects who, in the opinion of the investigator, are not likely to survive beyond 48
hours from Baseline.

- Subjects who are considered to require concurrent therapy with another influenza
antiviral medication.

- Subjects who are known or suspected to be hypersensitive to any component of the study
medications.

- Subjects with creatinine clearance =10 mL/min who are not being treated with
continuous renal replacement therapy (CRRT).

- Subjects who require Extra Corporeal Membrane Oxygenation (ECMO) at Baseline

- Subjects who require routine/intermittent hemodialysis or continuous peritoneal
dialysis (due to inability to provide appropriate dosing schedule for oseltamivir) at
Baseline. CRRT modalities are allowed.

- Liver toxicity criteria based on local laboratory results obtained within 24 hours of
Baseline:

1. ALT or AST 3xULN and bilirubin 2xULN

2. ALT 5xULN

- Underlying chronic liver disease with evidence of severe liver impairment.

- History of severe cardiac disease or clinically significant arrhythmia (either on ECG
or by history) which, in the opinion of the Investigator, will interfere with the
safety of the individual subject.

- Females who are pregnant or are breastfeeding.

- Treatment with investigational parenteral anti-influenza drugs (IV peramivir, IV
zanamivir or IV oseltamivir) in the 4 weeks prior to Baseline.

- French and Korean subjects: the French or Korean subject has participated in any study
using an investigational drug during the previous 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/03/2015
Sample size
Target
Accrual to date
Final
626
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [2] 0 0
GSK Investigational Site - Herston
Recruitment hospital [3] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [6] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [7] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [8] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5043 - Bedford Park
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Melbourne
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Kansas
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Kentucky
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Massachusetts
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Michigan
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Missouri
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Montana
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Nevada
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New York
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United States of America
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North Carolina
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United States of America
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North Dakota
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Ohio
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Pennsylvania
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Texas
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Virginia
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Wisconsin
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Brussel
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Belgium
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Bruxelles
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Leuven
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Liege
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Rio de Janeiro
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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Nova Scotia
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Ontario
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Quebec
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China
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Hainan
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Hunan
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Jiangxi
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Jilin
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Zhejiang
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Beijing
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Chengdu
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China
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Chongqing
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China
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Guangzhou
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China
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Hangzhou
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China
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Shanghai
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China
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Tianjin
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Colombia
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Bogotá
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Czechia
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Brno - Bohunice
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha 8
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Denmark
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Aarhus N
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Denmark
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Hvidovre
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Denmark
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Odense C
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France
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Dijon Cedex
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France
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Limoges cedex
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France
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Nîmes cedex 9
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France
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Orléans cedex 2
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France
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Poitiers Cedex
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France
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Tours cedex 9
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Saarland
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Greece
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Chaidari
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Greece
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Goudi, Athens
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Hong Kong
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Kwun Tong
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Hong Kong
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Shatin
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Hong Kong
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Tuen Mun
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Hungary
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Debrecen
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Kaposvár
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Hungary
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Miskolc
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Szombathely
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India
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Bangalore
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India
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Civil Lines
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Lucknow
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India
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Pune
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India
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Trivandrum
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Korea, Republic of
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Guro Gu
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Korea, Republic of
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Gyeonggi
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Korea, Republic of
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Kangwon-do
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Korea, Republic of
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Seoul
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Mexico
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Estado De México
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Netherlands
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Nijmegen
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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New Zealand
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Hastings
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New Zealand
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Newtown
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Norway
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Bergen
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Norway
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Trondheim
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Poland
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Chorzow
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Poland
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Debica
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Poland
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Trzebnica
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Poland
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Warszawa
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Russian Federation
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Barnaul
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Smolensk
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Slovakia
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Bratislava
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Slovakia
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Martin
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South Africa
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Mpumalanga
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South Africa
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Bellville
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South Africa
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Die Wilgers
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South Africa
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Les Marais
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South Africa
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Panorama
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South Africa
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Worcester
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Spain
State/province [115] 0 0
Alicante
Country [116] 0 0
Spain
State/province [116] 0 0
Badalona
Country [117] 0 0
Spain
State/province [117] 0 0
Barcelona
Country [118] 0 0
Spain
State/province [118] 0 0
Granada
Country [119] 0 0
Spain
State/province [119] 0 0
L'Hospitalet de Llobregat
Country [120] 0 0
Spain
State/province [120] 0 0
Madrid
Country [121] 0 0
Spain
State/province [121] 0 0
Murcia
Country [122] 0 0
Spain
State/province [122] 0 0
Oviedo
Country [123] 0 0
Spain
State/province [123] 0 0
Pama de Mallorca
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taipei
Country [125] 0 0
Thailand
State/province [125] 0 0
Bangkok
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Bristol
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Cardiff
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Liverpool
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to test the safety and efficacy of zanamivir given intravenously
and how well it works at two different doses in hospitalized adolescents and adults with flu.
Zanamivir will be compared with oseltamivir, which is used for treating flu.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01231620
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
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Contact person for scientific queries

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Results publications and other study-related documents

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Results are available at https://clinicaltrials.gov/ct2/show/NCT01231620