Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 37
- 主要终点
- Number of Patients in Each of 6 Clinical Status Categories on Day 7
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Number of Patients in Each of 6 Clinical Status Categories on Day 7
时间窗: 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).
次要结局
- Death or Re-hospitalization(Day 28)
- Percent of Participants Developing Complications(Measured through Day 28)
- Number of Patients in Each of 6 Clinical Status Categories on Day 28(day 28)
- Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7(Day 7)
- Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7(Day 7)
- Influenza B Titers at Day 7(Day 7)
- Number of Patients in Each of 5 Clinical Status Categories on Day 3(Assessed on Day 3)
- Mortality(Measured through day 28)
- Number of Patients Alive and Out of Hospital(Measured through Day 28)
- Number of Patients in Each of 6 Clinical Status Categories on Day 3(Measured on Day 3)
- pH1N1 Titers at Day 7(Day 7)
- Number of Patients With a Favorable Outcome on Day 7(Assessed on Day 7)
- Hospital Discharge(Measured through Day 7)
- Change in Viral Load(Day 3)
- Number of Patients Alive and Out of Hospital on Day 14(day 14)
- Number of Patients in Each of 6 Clinical Status Categories on Day 14(Measured on day 14)
- Resumption of Normal Activities by Day 14(day 14)
- H3N2 Titers at Day 7(Day 7)