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 : Completed
First Posted : November 10, 2014
Results First Posted : November 14, 2019
Last Update Posted : November 14, 2019
|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)|
|Actual Enrollment :||329 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|
|Actual Primary Completion Date :||June 7, 2018|
|Actual Study Completion Date :||June 7, 2018|
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)
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
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
Administered IV as 500 mL of normal saline
- Number of Patients in Each of 6 Clinical Status Categories on Day 7 [ Time Frame: Assessed 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).
- Number of Patients in Each of 5 Clinical Status Categories on Day 3 [ Time Frame: Assessed on Day 3 ]5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).
- Number of Patients in Each of 6 Clinical Status Categories on Day 3 [ Time Frame: Measured 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).
- Number of Patients With a Favorable Outcome on Day 7 [ Time Frame: Assessed on Day 7 ]Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.
- Hospital Discharge [ Time Frame: Measured through Day 7 ]Number of participants alive and discharged from the hospital
- Mortality [ Time Frame: Measured through day 28 ]Number of participants dying through day 28.
- Number of Patients Alive and Out of Hospital [ Time Frame: Measured through Day 28 ]Number and percent alive and out of hospital on day 28
- Change in Viral Load [ Time Frame: Day 3 ]Change in nasopharyngeal viral load from baseline to day 3
- Death or Re-hospitalization [ Time Frame: Day 28 ]Number and percent of participants who died or were re-hospitalized after initial discharge
- Percent of Participants Developing Complications [ Time Frame: Measured through Day 28 ]Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis
- Number of Patients in Each of 6 Clinical Status Categories on Day 14 [ Time Frame: Measured on day 14 ]6-category ordinal outcome measured on day 14
- Number of Patients Alive and Out of Hospital on Day 14 [ Time Frame: day 14 ]Number and percentage of participants alive and out of the hospital on Day 14
- Resumption of Normal Activities by Day 14 [ Time Frame: day 14 ]Participants reporting resumption of normal daily activities by Day 14
- Number of Patients in Each of 6 Clinical Status Categories on Day 28 [ Time Frame: day 28 ]6-category ordinal outcome corresponding to clinical status on day 28
- Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7 [ Time Frame: Day 7 ]Primary 6-category ordinal outcome for participants infected with Influenza A
- Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7 [ Time Frame: Day 7 ]Primary 6-category ordinal outcome for subgroup of participants infected with influenza B
- pH1N1 Titers at Day 7 [ Time Frame: Day 7 ]pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus
- H3N2 Titers at Day 7 [ Time Frame: Day 7 ]H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus
- Influenza B Titers at Day 7 [ Time Frame: Day 7 ]Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus
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
|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|