Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza

Completed · Phase 2

Conditions studied: Influenza A, Influenza B

In brief

This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.

Key facts

Study ID

NCT01052480

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

98

Starts

2010-12-01

Expected to finish

2015-11-01

Last updated by the study team

2017-09-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of influenza A or B within 72 hours prior to enrollment (by local assay including rapid antigen, direct fluorescent antibody (DFA), polymerase chain reaction (PCR), or culture, and must be able to detect and distinguish influenza A from influenza B)
• Hospitalization for signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).
• Abnormal respiratory status, defined as room air saturation of oxygen (SaO2) less than 93% or tachypnea (respiratory rate above an age adjusted normal range)
• Agree to the storage of specimens and data
• ABO compatible plasma available on site or available within 24 hours after randomization with activity against locally circulating strains of influenza

You may not qualify if…

• Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to receive any time during the study). This does not include licensed drugs at non approved doses, off-label indications, or drugs available under an Emergency Use Authorization (EUA).
• History of severe allergic reaction to blood products (as judged by the investigator).
• Medical conditions for which receipt of 500 mL volume (or 8 mL/kg for pediatric patients) may be dangerous to the subject (e.g. decompensated congestive heart failure [CHF], etc.)
• Clinical suspicion that etiology of acute illness is primarily due to a condition other than active influenza virus replication (e.g., a bacterial or fungal infection)

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Naval Medical Center San Diego — San Diego, California, United States
• Los Angeles Biomedical Research Institute, CA — Torrance, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Washington, DC VA Med Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern University (NU) — Chicago, Illinois, United States
• The Rush University Medical Center — Chicago, Illinois, United States
• University of Maryland School of Medicine Center for Vaccine Development — Baltimore, Maryland, United States
• John Hopkins University (JHU) — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center (WRNMMC) — Bethesda, Maryland, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital/Harvard Medical School — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston Med Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Bronson Healthcare Group — Kalamazoo, Michigan, United States
• Saint Mary's Hospital (Mayo Clinic) — Rochester, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College — New York, New York, United States
• Montefiore Medical Center/Albert Einstein College of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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