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

NCT01052480 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 10-I-0043IRC002
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 35

Brief Summary

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.

Conditions

Influenza A; Influenza B

Keywords

Antiviral; Anti-Influenza Immune Plasma; Emerging Infectious Disease; Swine Flu

Outcome Measures

Primary Outcomes (1)

• Time to Normalization of Respiratory Status (Primary Efficacy Population)

  Normalized respiratory status is defined as room air saturation of oxygen \[SaO2\] greater than or equal to 93% AND respiratory rate within normal ranges.

  Measured from Day 0 through Day 28

Secondary Outcomes (21)

• Time to Normalization of Respiratory Status (All Randomized Participants)

  Measured from Day 0 through Day 28

• Duration of Time to Resolution of Clinical Symptoms

  Measured from Day 0 through Day 28

• Duration of Time to Resolution of Fever

  Measured from Day 0 through Day 28

• Duration of Time to Resolution of All Symptoms and Fever

  Measured from Day 0 through Day 28

• Time to 20% Improvement in Sequential Organ Failure Assessment (SOFA) Score for Participants >= 18 Years Old and Pediatric Logistic Organ Dysfunction (PELOD) Score for Participants < 18 Years Old

  Measured from Day 0 through Day 28

Study Arms (2)

Plasma and Standard Care

EXPERIMENTAL

Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies (Anti-Influenza Immune Plasma) in addition to standard care.

Biological: Anti-Influenza Immune Plasma; Drug: Standard Care

Standard Care

ACTIVE COMPARATOR

Participants will receive standard care.

Drug: Standard Care

Interventions

Anti-Influenza Immune Plasma BIOLOGICAL

2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline

Plasma and Standard Care

Standard Care DRUG

All subjects will receive an anti-influenza antiviral (e.g., oseltamivir or zanamivir), but may include treatment with licensed antivirals in patient populations or at doses not covered in the package insert, or with medications available under a EUA. Standard care may also include antibiotics and other medications.

Plasma and Standard Care; Standard Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (35)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-1752, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Los Angeles Biomedical Research Institute, CA

Torrance, California, 90502, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Washington, DC VA Med Center

Washington D.C., District of Columbia, 20422, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University (NU)

Chicago, Illinois, 60611, United States

Location

The Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Maryland School of Medicine Center for Vaccine Development

Baltimore, Maryland, 21201, United States

Location

John Hopkins University (JHU)

Baltimore, Maryland, 21218, United States

Location

Walter Reed National Military Medical Center (WRNMMC)

Bethesda, Maryland, 20889, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital/Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Med Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Bronson Healthcare Group

Kalamazoo, Michigan, 49007, United States

Location

Saint Mary's Hospital (Mayo Clinic)

Rochester, Minnesota, 55905, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College

New York, New York, 10065, United States

Location

Montefiore Medical Center/Albert Einstein College of Medicine

New York, New York, 10467, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267-0405, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Tech University Health Science Center (HSC)- Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Texas Tech HSC-Lubbock, TX

Lubbock, Texas, 79430, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Medical Center (MAMC)

Tacoma, Washington, 98431, United States

Location

Related Publications (4)

• Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.

  PMID: 8903148 BACKGROUND

• Bean WJ, Schell M, Katz J, Kawaoka Y, Naeve C, Gorman O, Webster RG. Evolution of the H3 influenza virus hemagglutinin from human and nonhuman hosts. J Virol. 1992 Feb;66(2):1129-38. doi: 10.1128/JVI.66.2.1129-1138.1992.

  PMID: 1731092 BACKGROUND

• de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72. doi: 10.1056/NEJMoa054512.

  PMID: 16371632 BACKGROUND

• Beigel JH, Tebas P, Elie-Turenne MC, Bajwa E, Bell TE, Cairns CB, Shoham S, Deville JG, Feucht E, Feinberg J, Luke T, Raviprakash K, Danko J, O'Neil D, Metcalf JA, King K, Burgess TH, Aga E, Lane HC, Hughes MD, Davey RT; IRC002 Study Team. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study. Lancet Respir Med. 2017 Jun;5(6):500-511. doi: 10.1016/S2213-2600(17)30174-1. Epub 2017 May 15.

  PMID: 28522352 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Communicable Diseases, Emerging; Orthomyxoviridae Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: John Beigel, M.D.
• Organization: Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)

jbeigel@niaid.nih.gov

301-451-9881

Study Officials

• John Beigel, MD

  Leidos Biomedical Research, Inc. in support of Laboratory of Immunoregulation, NIAID, NIH

  STUDY CHAIR

• Richard Davey, MD

  Laboratory of Immunoregulation, NIAID, NIH

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2010
• First Posted: January 20, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 5, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-06

Locations

US (35)