Status:
COMPLETED
Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A
Lead Sponsor:
Emergent BioSolutions
Conditions:
Influenza A H3N2
Influenza A H1N1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with t...
Eligibility Criteria
Inclusion
- Provision of voluntary informed consent in writing by patient, or legally authorized representative.
- Age ≥ 18 years of age.
- Locally determined positive influenza A infection (Rapid Antigen (Ag) Test or PCR) from a specimen obtained within 2 days prior to randomization.
- Onset of symptoms ≤ 6 days before randomization, defined as when the patient first experienced at least one respiratory symptom or fever.
- Hospitalized (or in observation unit) with influenza, with anticipated hospitalization for more than 24 hours and will be/already are receiving antiviral SOC.
- Experiencing ≥ 1 respiratory symptom (ex. cough, sore throat, nasal congestion) and ≥ 1 constitutional symptom (ex. headache, myalgia, feverishness or fatigue).
- For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least 1 form of hormonal or barrier contraception through Day 60 of the study.
- Willingness to have blood and respiratory samples obtained and stored.
- National Early Warning Score (NEW score) ≥ 3 at screening.
Exclusion
- Use of any investigational product within the past 30 days prior to screening.
- History of hypersensitivity to blood or plasma products (as judged by the site investigator).
- History of allergy to latex or rubber.
- Known medical history of IgA deficiency.
- Pregnancy or lactation.
- Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the patient (e.g. decompensated congestive heart failure), based on investigator's medical opinion with careful consideration of lab results.
- Liver function: liver function test (LFT) \> 2.5 times upper limit of normal (ULN).
- Renal Function: glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2 (age and sex adjusted).
- A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g. cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy).
- An opinion of the investigator that it would be unwise to allow participation of the patient in the study (the reason for exclusion of the patient must be documented).
- Receiving extracorporeal membrane oxygenation (ECMO).
- Anticipated life expectancy of \< 90 days.
- Confirmed bacterial pneumonia or any concurrent respiratory viral infection that is not influenza A (ex. respiratory syncytial virus (RSV) infection).
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2019
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03315104
Start Date
November 17 2017
End Date
June 17 2019
Last Update
March 18 2024
Active Locations (55)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
HonorHealth
Scottsdale, Arizona, United States, 85258
3
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
4
University of California, Irvine Emergency Medicine
Orange, California, United States, 92868