Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
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|ClinicalTrials.gov Identifier: NCT02287467|
Recruitment Status : Recruiting
First Posted : November 10, 2014
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Influenza A Influenza B||Biological: Intravenous hyperimmune immunoglobulin (IVIG) Biological: Placebo for IVIG||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
Experimental: Arm A: IVIG and standard of care (SOC) treatment
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Biological: 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)
Placebo Comparator: Arm B: Placebo for IVIG and SOC treatment
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Biological: Placebo for IVIG
Administered IV as 500 mL of normal saline
- Percent of participants who die by Day 7 [ Time Frame: Measured through Day 7 ]
- Percent of participants in the intensive care unit (ICU) at Day 7 [ Time Frame: Measured at Day 7 ]
- Percent of non-ICU hospitalized participants requiring supplemental oxygen at Day 7 [ Time Frame: Measured at Day 7 ]
- Percent of non-ICU hospitalized participants not requiring supplemental oxygen at Day 7 [ Time Frame: Measured at Day 7 ]
- Percent of participants who are not hospitalized, but who are unable to resume normal activities at Day 7 [ Time Frame: Measured at Day 7 ]
- Percent of participants who are not hospitalized and have fully resumed normal activities at Day 7 [ Time Frame: Measured at Day 7 ]
- Change in National Early Warning (NEW) score from baseline to Day 3 [ Time Frame: Measured at Day 3 ]
- Number of days participants hospitalized [ Time Frame: Measured through Day 28 ]
- Composite of mortality or hospitalization at Days 7, 14, and 28 [ Time Frame: Measured through Day 28 ]
- Among participants not enrolled in the ICU, number who require invasive mechanical ventilation or admission to the ICU [ Time Frame: Measured through Day 28 ]
- Percent of participants shedding virus at Day 3 [ Time Frame: Measured at Day 3 ]
- Hemagglutination inhibition (HAI) antibody level changes through Day 7 [ Time Frame: Measured through Day 7 ]
- Number of Grade 3 and 4 adverse events [ Time Frame: Measured through Day 28 ]
- Number of serious adverse events [ Time Frame: Measured through Day 28 ]
- Percent of participants developing bronchitis, pneumonia, or other complications through Day 28 [ Time Frame: Measured through Day 28 ]
- Number of participants who die [ Time Frame: Measured through Day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287467
Show 21 Study Locations
|Study Chair:||Richard T. Davey, Jr., MD||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Chair:||Eduardo Fernández-Cruz, MD, PhD||Hospital General Universitario Gregorio Marañón|
|Study Chair:||Norman P. Markowitz, MD||The Henry Ford Hospital|
|Study Chair:||Sarah L. Pett, MD, MBBS, DTM, MRCP (UK)||University College, London|