Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02572817|
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : May 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Influenza A Virus Infection||Biological: High-titer anti-influenza plasma Biological: Low-titer (control) anti-influenza plasma||Phase 3|
Despite antivirals and vaccines, influenza is responsible for thousands of hospitalizations and deaths each year worldwide. Because of this, additional treatments for influenza are needed. One potential treatment may be the use of high-titer anti-influenza immune plasma. The purpose of this study is to evaluate the efficacy and safety of treatment with high-titer versus low-titer anti-influenza immune plasma, in addition to standard care, in participants hospitalized with severe influenza A infection.
This study will enroll people aged 2 weeks or older who are hospitalized with severe influenza A infection. Participants will be randomly assigned to receive either high-titer anti-influenza plasma or low-titer (control) anti-influenza plasma on Day 0. In addition, all participants will receive standard care antivirals. Participants will be assessed on Day 0 (baseline) and on Days 1, 2, 3, 7, 14, and 28. For participants who are not hospitalized on Days 2, 14, and 28, researchers may contact participants by telephone. Study procedures will include clinical assessments, blood collection, and oropharyngeal swabs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: High-titer anti-influenza plasma
Participants will receive two intravenous infusions of high-titer anti-influenza plasma on Study Day 0.
Biological: High-titer anti-influenza plasma
Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of at least 1:80
Active Comparator: Low-titer (control) anti-influenza plasma
Participants will receive two intravenous infusions of low-titer anti-influenza plasma on Study Day 0.
Biological: Low-titer (control) anti-influenza plasma
Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of 1:10 or less
- Subjects clinical status at Day 7 (6-point ordinal scale) [ Time Frame: Measured at Day 7 ]
- In ICU
- Non-ICU hospitalization, requiring supplemental oxygen
- Non-ICU hospitalization, not requiring supplemental oxygen
- Not hospitalized, but unable to resume normal activities
- Not hospitalized with full resumption of normal activities
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): NCT02572817
|Contact: DCR Flu Operations||DCRFluOperations@s-3.com|
Show 41 Study Locations
|Study Chair:||John Beigel, MD||Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, National Institutes of Health|