Phase 3
N=329
Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
Influenza A · Influenza B
Bottom Line
View on ClinicalTrials.gov: NCT02287467 ↗Enrolled (actual)
329
Serious AEs
16.6%
Results posted
Nov 2019
Primary outcome: Primary: Number of Patients in Each of 6 Clinical Status Categories on Day 7 — 3; 2; 6; 11 Participants — p=.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intravenous hyperimmune immunoglobulin (IVIG) (Biological); Placebo for IVIG (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Each of 6 Clinical Status Categories on Day 7 |
3; 2; 6; 11; 15; 16 | .33 |
| SECONDARY Number of Patients in Each of 5 Clinical Status Categories on Day 3 |
1; 0; 8; 13; 25; 31 | .84 |
| SECONDARY Number of Patients in Each of 6 Clinical Status Categories on Day 3 |
1; 0; 8; 13; 37; 34 | .52 |
| SECONDARY Number of Patients With a Favorable Outcome on Day 7 |
128; 115; 28; 37 | .20 |
| SECONDARY Hospital Discharge |
119; 110; 37; 42 | .44 |
| SECONDARY Mortality |
6; 5; 150; 147 | .40 |
| SECONDARY Number of Patients Alive and Out of Hospital |
140; 137; 15; 14 | .74 |
| SECONDARY Change in Viral Load |
-1.99; -2.32 | .49 |
| SECONDARY Death or Re-hospitalization |
19; 19 | .93 |
| SECONDARY Percent of Participants Developing Complications |
20; 22 | .81 |
| SECONDARY Number of Patients in Each of 6 Clinical Status Categories on Day 14 |
4; 4; 5; 6; 8; 5 | .55 |
| SECONDARY Number of Patients Alive and Out of Hospital on Day 14 |
134; 125 | .77 |
| SECONDARY Resumption of Normal Activities by Day 14 |
102; 92 | .34 |
| SECONDARY Number of Patients in Each of 6 Clinical Status Categories on Day 28 |
6; 5; 2; 2; 6; 2 | .73 |
| SECONDARY Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7 |
3; 0; 5; 7; 14; 9 | .82 |
| SECONDARY Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7 |
0; 2; 1; 4; 1; 7 | .02 sig |
| SECONDARY pH1N1 Titers at Day 7 |
285; 229 | .18 |
| SECONDARY H3N2 Titers at Day 7 |
259; 225 | .13 |
| SECONDARY Influenza B Titers at Day 7 |
112; 84 | .78 |
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.
Eligibility Criteria
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
- 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)
Data sourced from ClinicalTrials.gov (NCT02287467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.