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CompletedNCT02287467Updated Nov 14, 2019Results posted

Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza

A Phase 3 interventional study of Intravenous hyperimmune immunoglobulin (IVIG) and Placebo for IVIG in Influenza A and Influenza B, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 21 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-14.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
329
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Influenza is responsible for thousands of hospitalizations and deaths each year in the United States and worldwide. One possible new treatment for the flu involves the use of IVIG, a blood product containing antibodies from people who have recovered from the flu or who have had a flu shot. The purpose of this study is to evaluate whether IVIG can reduce the severity and duration of flu in people who are hospitalized with the flu.

The study will enroll participants 18 years and older who are hospitalized with the flu. The study will enroll participants over one or more flu seasons. Regardless of the date of enrollment, each participant will be in the study for about 28 days.

At study entry (Day 0), participants will be randomly assigned to one of two groups (Arms A and B). Participants in both groups will receive standard of care (SOC) treatment for the flu, but those in Arm A will also receive one dose of IVIG and those in Arm B will receive a placebo for IVIG. Both IVIG and placebo will be given intravenously over at least 2 hours.

On Day 0, before receiving IVIG or placebo, participants will undergo a symptoms assessment, blood collection, and a nasopharyngeal (NP) swab to collect a sample of secretions from the nose and throat.

Additional study visits will occur on Days 1, 2, 3, 7, 14, and 28. Depending on the visit, participants may take part in the same study procedures that took place on Day 0. On Days 2, 14, and 28, visits for participants who are no longer hospitalized may be conducted over the phone.

02

Conditions studied

  • Influenza A
  • Influenza B

Browse trials for

Keywords

  • Antiviral
  • IVIG
  • Hemagglutination inhibition (HAI)
  • Antibody
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 329 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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)

Exclusion criteria

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
329 participants (actual)

Study arms

  • 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.

    Biological: Intravenous hyperimmune immunoglobulin (IVIG)

  • 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.

    Biological: Placebo for IVIG

Interventions

  • BiologicalIntravenous 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)

  • BiologicalPlacebo for IVIG

    Administered IV as 500 mL of normal saline

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Assessed on Day 7

Secondary outcomes

  1. 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).

    Time frame: Assessed on Day 3

  2. 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).

    Time frame: Measured on Day 3

  3. 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.

    Time frame: Assessed on Day 7

  4. Hospital Discharge

    Number of participants alive and discharged from the hospital

    Time frame: Measured through Day 7

  5. Mortality

    Number of participants dying through day 28.

    Time frame: Measured through day 28

  6. Number of Patients Alive and Out of Hospital

    Number and percent alive and out of hospital on day 28

    Time frame: Measured through Day 28

  7. Change in Viral Load

    Change in nasopharyngeal viral load from baseline to day 3

    Time frame: Day 3

  8. Death or Re-hospitalization

    Number and percent of participants who died or were re-hospitalized after initial discharge

    Time frame: Day 28

  9. Percent of Participants Developing Complications

    Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis

    Time frame: Measured through Day 28

  10. Number of Patients in Each of 6 Clinical Status Categories on Day 14

    6-category ordinal outcome measured on day 14

    Time frame: Measured on day 14

  11. 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

    Time frame: day 14

  12. Resumption of Normal Activities by Day 14

    Participants reporting resumption of normal daily activities by Day 14

    Time frame: day 14

  13. Number of Patients in Each of 6 Clinical Status Categories on Day 28

    6-category ordinal outcome corresponding to clinical status on day 28

    Time frame: day 28

  14. 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

    Time frame: Day 7

  15. 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

    Time frame: Day 7

  16. pH1N1 Titers at Day 7

    pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus

    Time frame: Day 7

  17. H3N2 Titers at Day 7

    H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus

    Time frame: Day 7

  18. Influenza B Titers at Day 7

    Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus

    Time frame: Day 7

07

Results

Posted Nov 14, 2019

Participant flow

Participant flow — Overall Study
MilestoneArm A: hIVIGArm B: Placebo
Started168161
Completed156152
Not completed129
Withdrew: Protocol violation129

Outcome measures

PrimaryNumber 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).

Time frame:
Assessed on Day 7
Reported as:
Count of participants · Participants
Number of Patients in Each of 6 Clinical Status Categories on Day 7
ParticipantsArm A: hIVIGArm B: Placebo
Died32
Hospitalized, in ICU611
Non-ICU hospitalization, using supplemental oxygen1516
Non-ICU hospitalization, no supplemental oxygen812
Discharged, not back to normal activities5651
Discharged, back to normal activities6860
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .33 · Odds ratio (or): 1.25 · 95% CI 0.79 to 1.97Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.
SecondaryNumber 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).

Time frame:
Assessed on Day 3
Reported as:
Count of participants · Participants
Number of Patients in Each of 5 Clinical Status Categories on Day 3
ParticipantsArm A: hIVIGArm B: Placebo
Death10
Hospitalized, in ICU813
Non-ICU hospitalization, NEW score 3+2531
Non-ICU hospitalization, NEW score < 35546
Discharged6762
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .84 · Odds ratio (or): 0.95 · 95% CI 0.61 to 1.48Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.
SecondaryNumber 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).

Time frame:
Measured on Day 3
Reported as:
Count of participants · Participants
Number of Patients in Each of 6 Clinical Status Categories on Day 3
ParticipantsArm A: hIVIGArm B: Placebo
Death10
Hospitalized, in ICU813
Non-ICU hospitalization, on supplemental oxygen3734
Non-ICU hospitalizaiton, no supplemental oxygen4343
Discharged, not back to normal activities5353
Discharged, back to normal activities139
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Cox · p = .52 · Odds ratio (or): 0.87 · 95% CI 0.57 to 1.33Odds ratio is for hIVIG vs. placebo. An odds ratio \> 1 favors the hIVIG group.
SecondaryNumber 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.

Time frame:
Assessed on Day 7
Reported as:
Count of participants · Participants
Number of Patients With a Favorable Outcome on Day 7
ParticipantsArm A: hIVIGArm B: Placebo
favorable outcome128115
unfavorable outcome2837
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .20 · Odds ratio (or): 1.49 · 95% CI 0.81 to 2.74Odds ratio for hIVIG vs placebo. An odds ratio \> 1.0 favors the hIVIG group.
SecondaryHospital Discharge

Number of participants alive and discharged from the hospital

Time frame:
Measured through Day 7
Reported as:
Count of participants · Participants
Hospital Discharge
ParticipantsArm A: hIVIGArm B: Placebo
Discharged alive119110
Not discharged alive3742
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Cox · p = .44 · Hazard ratio (hr): 1.11 · 95% CI .85 to 1.45hazard ratio is hIVIG vs placebo; a hazard ratio \>1 favors the hIVIG group.
SecondaryMortality

Number of participants dying through day 28.

Time frame:
Measured through day 28
Reported as:
Count of participants · Participants
Mortality
ParticipantsArm A: hIVIGArm B: Placebo
Died65
Did not die150147
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Cox · p = .40 · Hazard ratio (hr): 1.72 · 95% CI .48 to 6.15hazard ratio is for hIVIG vs placebo; a hazard ratio \< 1.0 favors the hIVIG group.
SecondaryNumber of Patients Alive and Out of Hospital

Number and percent alive and out of hospital on day 28

Time frame:
Measured through Day 28
Reported as:
Count of participants · Participants
Number of Patients Alive and Out of Hospital
ParticipantsArm A: hIVIGArm B: Placebo
Alive and out of hospital140137
Died or hospitalized1514
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .74 · Odds ratio (or): 0.87 · 95% CI .38 to 1.98odds ratio is for hIVIG vs placebo; an odds ratio \> 1.0 favors hIVIG
SecondaryChange in Viral Load

Change in nasopharyngeal viral load from baseline to day 3

Time frame:
Day 3
Reported as:
Mean · log10 RNA
Change in Viral Load
log10 RNAArm A: hIVIGArm B: Placebo
Change in Viral Load-1.99 ± .16-2.32 ± .17
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Linear · p = .49 · Mean difference (net): 0.14 · 95% CI -.26 to .54Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.
SecondaryDeath or Re-hospitalization

Number and percent of participants who died or were re-hospitalized after initial discharge

Time frame:
Day 28
Reported as:
Count of participants · Participants
Death or Re-hospitalization
ParticipantsArm A: hIVIGArm B: Placebo
Death or Re-hospitalization1919
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .93 · Odds ratio (or): 0.97 · 95% CI 0.5 to 1.97Odds ratio is for hIVIG vs placebo.
SecondaryPercent of Participants Developing Complications

Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis

Time frame:
Measured through Day 28
Reported as:
Count of participants · Participants
Percent of Participants Developing Complications
ParticipantsArm A: hIVIGArm B: Placebo
Percent of Participants Developing Complications2022
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .81 · Odds ratio (or): 0.92 · 95% CI 0.5 to 1.82odds ratio is for hIVIG group vs placebo
SecondaryNumber of Patients in Each of 6 Clinical Status Categories on Day 14

6-category ordinal outcome measured on day 14

Time frame:
Measured on day 14
Reported as:
Count of participants · Participants
Number of Patients in Each of 6 Clinical Status Categories on Day 14
ParticipantsArm A: hIVIGArm B: Placebo
Died44
Hospitalized in ICU56
Hospitalized on supplement oxygen85
Hospitalized not on supplemental oxygen411
Discharged, not back to normal activities2933
Discharged, back to normal activities10292
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .55 · Odds ratio (or): 1.17 · 95% CI 0.70 to 1.95Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio \> 1 favors the hIVIG group.
SecondaryNumber of Patients Alive and Out of Hospital on Day 14

Number and percentage of participants alive and out of the hospital on Day 14

Time frame:
day 14
Reported as:
Count of participants · Participants
Number of Patients Alive and Out of Hospital on Day 14
ParticipantsArm A: hIVIGArm B: Placebo
Number of Patients Alive and Out of Hospital on Day 14134125
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .77 · Odds ratio (or): 1.12 · 95% CI .5 to 2.31odds ratio is for hIVIG vs placebo
SecondaryResumption of Normal Activities by Day 14

Participants reporting resumption of normal daily activities by Day 14

Time frame:
day 14
Reported as:
Count of participants · Participants
Resumption of Normal Activities by Day 14
ParticipantsArm A: hIVIGArm B: Placebo
Resumption of Normal Activities by Day 1410292
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .34 · Odds ratio (or): 1.32 · 95% CI 0.7 to 2.34odds ratio is expressed as hIVIG vs placebo
SecondaryNumber of Patients in Each of 6 Clinical Status Categories on Day 28

6-category ordinal outcome corresponding to clinical status on day 28

Time frame:
day 28
Reported as:
Count of participants · Participants
Number of Patients in Each of 6 Clinical Status Categories on Day 28
ParticipantsArm A: hIVIGArm B: Placebo
Died65
Hospitalized in ICU22
Hospitalized, on supplemental oxygen62
Hospitalized, not on supplemental oxygen15
Discharged, not back to normal activities2122
Discharged, back to normal activities115114
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .73 (adjusted for baseline clinical status, region, and participation in pilot study) · Odds ratio (or): .90 · 95% CI .50 to 1.62odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio \>1 favors the hIVIG group.
SecondaryNumber 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

Time frame:
Day 7
Reported as:
Count of participants · Participants
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
ParticipantsArm A: hIVIGArm B: Placebo
Died30
Hospitalized in ICU57
Hospitalized on supplemental oxygen149
Hospitalized not on supplemental oxygen710
Discharged, not back to normal activities4039
Discharged, back to normal activities4545
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .82 · Odds ratio (or): 0.94 · 95% CI 0.55 to 1.59Odds ratio (hIVIG vs placebo) is for being in a better category.
SecondaryNumber 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

Time frame:
Day 7
Reported as:
Count of participants · Participants
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
ParticipantsArm A: hIVIGArm B: Placebo
Died02
Hospitalized in ICU14
Hospitalized on supplemental oxygen17
Hospitalized not on supplemental oxygen12
Discharged, not back to normal activities1612
Discharged, back to normal activities2315
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Regression, Logistic · p = .02 · Odds ratio (or): 3.19 · 95% CI 1.21 to 8.42Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio \> 1 favors the hIVIG group.
SecondarypH1N1 Titers at Day 7

pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus

Time frame:
Day 7
Reported as:
Mean · titer
pH1N1 Titers at Day 7
titerArm A: hIVIGArm B: Placebo
pH1N1 Titers at Day 7285 ± 374229 ± 341
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Mixed Models Analysis · p = .18 · Ratio of geometric means: 1.50 · 95% CI 0.84 to 2.7Ratio of hIVIG group to placebo group. A ratio \> 1.0 indicates higher titers for the hIVIG group.
SecondaryH3N2 Titers at Day 7

H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus

Time frame:
Day 7
Reported as:
Mean · titer
H3N2 Titers at Day 7
titerArm A: hIVIGArm B: Placebo
H3N2 Titers at Day 7259 ± 291225 ± 277
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Mixed Models Analysis · p = .13 · Ratio of geometric means: 1.31 · 95% CI 0.93 to 1.8Ratio of geometric means of hIVIG vs placebo. A ratio \>1.0 indicates higher titers in the hIVIG group on day 7.
SecondaryInfluenza B Titers at Day 7

Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus

Time frame:
Day 7
Reported as:
Mean · titer
Influenza B Titers at Day 7
titerArm A: hIVIGArm B: Placebo
Influenza B Titers at Day 7112 ± 16184 ± 83
Statistical analysis
  • Arm A: hIVIG vs Arm B: Placebo · Mixed Models Analysis · p = .78 · Ratio of geometric means: 0.94 · 95% CI 0.58 to 1.5ratio of geometric mean for hIVIG vs placebo. A ratio \> 1.0 indicates higher titers at day 7 for the hIVIG group.

Adverse events

Collected over 28 days. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A: hIVIG6/156 (3.8%)25/156 (16%)13/156 (8.3%)
Arm B: Placebo5/152 (3.3%)26/152 (17.1%)14/152 (9.2%)
Most frequent serious events
Showing 10 of 51
Most frequent serious events
EventArm A: hIVIGArm B: Placebo
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders1/1565/152
Atrial fibrillationCardiac disorders0/1562/152
Acute kidney injuryRenal and urinary disorders0/1562/152
Respiratory failureRespiratory, thoracic and mediastinal disorders1/1562/152
Acute myocardial infarctionCardiac disorders2/1560/152
InfluenzaInfections and infestations2/1560/152
Pulmonary embolismRespiratory, thoracic and mediastinal disorders2/1560/152
LeukopeniaBlood and lymphatic system disorders0/1561/152
Cardiac failureCardiac disorders0/1561/152
Internal herniaGastrointestinal disorders0/1561/152
Most frequent other events
Most frequent other events
EventArm A: hIVIGArm B: Placebo
CoughRespiratory, thoracic and mediastinal disorders5/1564/152
Haemoglobin decreasedInvestigations2/1564/152
HyperglycaemiaMetabolism and nutrition disorders1/1564/152
MyalgiaMusculoskeletal and connective tissue disorders2/1564/152
Blood creatinine increasedInvestigations4/1561/152
DyspnoeaRespiratory, thoracic and mediastinal disorders4/1563/152

Baseline characteristics

Participants in the analysis data set.

Age, Categorical
Age, Categorical(Participants)Arm A: hIVIGArm B: PlaceboTotal
<=18 years112
Between 18 and 65 years109100209
>=65 years465197
Age, Continuous
Age, Continuous(years)Arm A: hIVIGArm B: PlaceboTotal
Median55 (41 to 68)57 (48 to 68)57 (45 to 68)
Sex: Female, Male
Sex: Female, Male(Participants)Arm A: hIVIGArm B: PlaceboTotal
Female8088168
Male7664140
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Arm A: hIVIGArm B: PlaceboTotal
Race/ethnicity — Asian333669
Race/ethnicity — Black/African American273057
Race/ethnicity — Hispanic272451
Race/ethnicity — White/Caucasian6761128
Race/ethnicity — Other213
Region of Enrollment
Region of Enrollment(Participants)Arm A: hIVIGArm B: PlaceboTotal
United States9184175
United Kingdom81018
Australia5510
Argentina448
Denmark538
Spain5510
Greece549
Mexico123
Thailand323567
National Early Warning (NEW) score
National Early Warning (NEW) score(units on a scale)Arm A: hIVIGArm B: PlaceboTotal
Median4 (2 to 6)4 (2 to 6)4 (2 to 6)
08

Study locations

21 sites
  • UCSD Antiviral Research Center (A VRC)
    San Diego, California 92103, United States
  • Denver Public Health
    Denver, Colorado 80204, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Minneapolis VA Medical Center
    Minneapolis, Minnesota 55417, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Cooper University Hospital
    Camden, New Jersey 08103, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • Cornell CRS
    New York, New York 10010, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • OHIO State University (OSU) Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Miami Valley Hospital
    Dayton, Ohio 45409, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75235, United States
  • West Virginia University
    Morgantown, West Virginia 26506, United States
  • Westmead Hospital
    Sydney, Australia
  • Odense University Hospital
    Odense, Denmark
  • St James's University Hospital
    Leeds, United Kingdom
  • Churchill Hospital
    Oxford, United Kingdom
09

References and documents

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. PubMed 31582358 ↗

Study documents

  • Statistical analysis plan · Aug 17, 2018
  • Study protocol · May 31, 2016

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02287467
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
University of Minnesota, International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Responsible party
Sponsor
First posted
Nov 10, 2014
Start date
Jan 2015
Primary completion
Jun 7, 2018
Completion
Jun 7, 2018
Results posted
Nov 14, 2019
Last update
Nov 14, 2019

Study contacts

Richard T. Davey, Jr., MD
study chair · National Institute of Allergy and Infectious Diseases (NIAID)
Eduardo Fernández-Cruz, MD, PhD
study chair · Hospital General Universitario Gregorio Marañón
Norman P. Markowitz, MD
study chair · The Henry Ford Hospital
Sarah L. Pett, MD, MBBS, DTM, MRCP (UK)
study chair · University College, London

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

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