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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
Secondary ID [1] 0 0
INSIGHT 006: FLU-IVIG
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Influenza B 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intravenous hyperimmune immunoglobulin (IVIG)
Other interventions - 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.


Other interventions: 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)

Other interventions: Placebo for IVIG
Administered IV as 500 mL of normal saline

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients in Each of 6 Clinical Status Categories on Day 7 - This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).
Timepoint [1] 0 0
Assessed on Day 7
Secondary outcome [1] 0 0
Number of Patients in Each of 5 Clinical Status Categories on Day 3 - 5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).
Timepoint [1] 0 0
Assessed on Day 3
Secondary outcome [2] 0 0
Number of Patients in Each of 6 Clinical Status Categories on Day 3 - 6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).
Timepoint [2] 0 0
Measured on Day 3
Secondary outcome [3] 0 0
Number of Patients With a Favorable Outcome on Day 7 - Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.
Timepoint [3] 0 0
Assessed on Day 7
Secondary outcome [4] 0 0
Hospital Discharge - Number of participants alive and discharged from the hospital
Timepoint [4] 0 0
Measured through Day 7
Secondary outcome [5] 0 0
Mortality - Number of participants dying through day 28.
Timepoint [5] 0 0
Measured through day 28
Secondary outcome [6] 0 0
Number of Patients Alive and Out of Hospital - Number and percent alive and out of hospital on day 28
Timepoint [6] 0 0
Measured through Day 28
Secondary outcome [7] 0 0
Change in Viral Load - Change in nasopharyngeal viral load from baseline to day 3
Timepoint [7] 0 0
Day 3
Secondary outcome [8] 0 0
Death or Re-hospitalization - Number and percent of participants who died or were re-hospitalized after initial discharge
Timepoint [8] 0 0
Day 28
Secondary outcome [9] 0 0
Percent of Participants Developing Complications - Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis
Timepoint [9] 0 0
Measured through Day 28
Secondary outcome [10] 0 0
Number of Patients in Each of 6 Clinical Status Categories on Day 14 - 6-category ordinal outcome measured on day 14
Timepoint [10] 0 0
Measured on day 14
Secondary outcome [11] 0 0
Number of Patients Alive and Out of Hospital on Day 14 - Number and percentage of participants alive and out of the hospital on Day 14
Timepoint [11] 0 0
day 14
Secondary outcome [12] 0 0
Resumption of Normal Activities by Day 14 - Participants reporting resumption of normal daily activities by Day 14
Timepoint [12] 0 0
day 14
Secondary outcome [13] 0 0
Number of Patients in Each of 6 Clinical Status Categories on Day 28 - 6-category ordinal outcome corresponding to clinical status on day 28
Timepoint [13] 0 0
day 28
Secondary outcome [14] 0 0
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7 - Primary 6-category ordinal outcome for participants infected with Influenza A
Timepoint [14] 0 0
Day 7
Secondary outcome [15] 0 0
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7 - Primary 6-category ordinal outcome for subgroup of participants infected with influenza B
Timepoint [15] 0 0
Day 7
Secondary outcome [16] 0 0
pH1N1 Titers at Day 7 - pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus
Timepoint [16] 0 0
Day 7
Secondary outcome [17] 0 0
H3N2 Titers at Day 7 - H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus
Timepoint [17] 0 0
Day 7
Secondary outcome [18] 0 0
Influenza B Titers at Day 7 - Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus
Timepoint [18] 0 0
Day 7

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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)

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
West Virginia
Country [14] 0 0
Denmark
State/province [14] 0 0
Odense
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Leeds
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Minnesota
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02287467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard T. Davey, Jr., MD
Address 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
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
Email 0 0
Contact person for scientific queries

Summary results
Other publications