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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02287467
Registration number
NCT02287467
Ethics application status
Date submitted
6/11/2014
Date registered
10/11/2014
Date last updated
14/11/2019
Titles & IDs
Public title
Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
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Scientific title
Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
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Secondary ID [1]
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INSIGHT 006: FLU-IVIG
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza A
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Influenza B
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Intravenous hyperimmune immunoglobulin (IVIG)
Treatment: Other - Placebo for IVIG
Experimental: Arm A: hIVIG - Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Placebo comparator: Arm B: Placebo - Participants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Treatment: Other: Intravenous hyperimmune immunoglobulin (IVIG)
Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
Treatment: Other: Placebo for IVIG
Administered IV as 500 mL of normal saline
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Patients in Each of 6 Clinical Status Categories on Day 7
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Assessment method [1]
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This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).
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Timepoint [1]
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Assessed on Day 7
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Secondary outcome [1]
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Number of Patients in Each of 5 Clinical Status Categories on Day 3
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Assessment method [1]
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5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).
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Timepoint [1]
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Assessed on Day 3
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Secondary outcome [2]
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Number of Patients in Each of 6 Clinical Status Categories on Day 3
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Assessment method [2]
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6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).
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Timepoint [2]
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Measured on Day 3
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Secondary outcome [3]
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Number of Patients With a Favorable Outcome on Day 7
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Assessment method [3]
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Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.
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Timepoint [3]
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Assessed on Day 7
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Secondary outcome [4]
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Hospital Discharge
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Assessment method [4]
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Number of participants alive and discharged from the hospital
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Timepoint [4]
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Measured through Day 7
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Secondary outcome [5]
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Mortality
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Assessment method [5]
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Number of participants dying through day 28.
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Timepoint [5]
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Measured through day 28
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Secondary outcome [6]
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Number of Patients Alive and Out of Hospital
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Assessment method [6]
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Number and percent alive and out of hospital on day 28
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Timepoint [6]
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Measured through Day 28
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Secondary outcome [7]
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Change in Viral Load
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Assessment method [7]
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Change in nasopharyngeal viral load from baseline to day 3
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Timepoint [7]
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Day 3
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Secondary outcome [8]
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Death or Re-hospitalization
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Assessment method [8]
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Number and percent of participants who died or were re-hospitalized after initial discharge
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Timepoint [8]
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Day 28
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Secondary outcome [9]
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Percent of Participants Developing Complications
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Assessment method [9]
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Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis
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Timepoint [9]
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Measured through Day 28
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Secondary outcome [10]
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Number of Patients in Each of 6 Clinical Status Categories on Day 14
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Assessment method [10]
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6-category ordinal outcome measured on day 14
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Timepoint [10]
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Measured on day 14
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Secondary outcome [11]
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Number of Patients Alive and Out of Hospital on Day 14
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Assessment method [11]
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Number and percentage of participants alive and out of the hospital on Day 14
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Timepoint [11]
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day 14
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Secondary outcome [12]
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Resumption of Normal Activities by Day 14
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Assessment method [12]
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Participants reporting resumption of normal daily activities by Day 14
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Timepoint [12]
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day 14
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Secondary outcome [13]
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Number of Patients in Each of 6 Clinical Status Categories on Day 28
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Assessment method [13]
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6-category ordinal outcome corresponding to clinical status on day 28
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Timepoint [13]
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day 28
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Secondary outcome [14]
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Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
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Assessment method [14]
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Primary 6-category ordinal outcome for participants infected with Influenza A
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Timepoint [14]
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Day 7
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Secondary outcome [15]
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Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
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Assessment method [15]
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Primary 6-category ordinal outcome for subgroup of participants infected with influenza B
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Timepoint [15]
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Day 7
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Secondary outcome [16]
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pH1N1 Titers at Day 7
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Assessment method [16]
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pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus
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Timepoint [16]
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Day 7
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Secondary outcome [17]
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H3N2 Titers at Day 7
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Assessment method [17]
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H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus
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Timepoint [17]
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Day 7
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Secondary outcome [18]
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Influenza B Titers at Day 7
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Assessment method [18]
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Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus
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Timepoint [18]
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Day 7
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Eligibility
Key inclusion criteria
* Signed informed consent
* Locally determined positive influenza test (by polymerase chain reaction [PCR] or other nucleic acid test, or by rapid antigen [Ag]) from a specimen obtained within 2 days prior to randomization
* Onset of illness no more than 7 days before randomization, defined as when the participant first experienced at least one respiratory symptom or fever
* Hospitalized (or in observation unit) for influenza, with anticipated hospitalization for more than 24 hours. Criteria for hospitalization will be up to the individual treating clinician.
* For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least one form of hormonal or barrier contraception through Day 28 of the study
* Willingness to have blood and respiratory samples obtained and stored
* NEW score greater than or equal to 2 at screening (see the protocol for more information on this criterion)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Women who are pregnant or breast-feeding
* Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin
* Prior treatment with any investigational drug therapy within 30 days prior to screening
* History of allergic reaction to blood or plasma products (as judged by the site investigator)
* Known immunoglobulin A (IgA) deficiency
* A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the participant at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)
* Presence of any pre-existing illness that, in the opinion of the site investigator, would place the participant at an unreasonably increased risk through participation in this study
* Participants who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol
* Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the participant (e.g., decompensated congestive heart failure)
* Receiving extracorporeal membrane oxygenation (ECMO)
* Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/06/2018
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Sample size
Target
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Accrual to date
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Final
329
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Michigan
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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State/province [7]
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New Jersey
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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North Carolina
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Country [10]
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United States of America
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State/province [10]
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Ohio
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Country [11]
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
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United States of America
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State/province [12]
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Texas
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Country [13]
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United States of America
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State/province [13]
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West Virginia
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Country [14]
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Denmark
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State/province [14]
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Odense
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Country [15]
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United Kingdom
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State/province [15]
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Leeds
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Country [16]
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United Kingdom
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State/province [16]
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Oxford
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Institute of Allergy and Infectious Diseases (NIAID)
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Address
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Other collaborator category [1]
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Other
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Name [1]
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University of Minnesota
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.
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Trial website
https://clinicaltrials.gov/study/NCT02287467
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Trial related presentations / publications
Davey RT Jr, Fernandez-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2019 Nov;7(11):951-963. doi: 10.1016/S2213-2600(19)30253-X. Epub 2019 Sep 30.
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Public notes
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Contacts
Principal investigator
Name
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Richard T. Davey, Jr., MD
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Address
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National Institute of Allergy and Infectious Diseases (NIAID)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/67/NCT02287467/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/67/NCT02287467/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02287467
Download to PDF