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Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza (IRC002)

Primary Purpose

Influenza A, Influenza B

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anti-Influenza Immune Plasma
Standard Care
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza A focused on measuring Antiviral, Anti-Influenza Immune Plasma, Emerging Infectious Disease, Swine Flu

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • David Geffen School of Medicine at UCLA
  • Naval Medical Center San Diego
  • Los Angeles Biomedical Research Institute, CA
  • Children's National Medical Center
  • Washington, DC VA Med Center
  • University of Florida
  • Emory University Hospital
  • Northwestern University (NU)
  • The Rush University Medical Center
  • University of Maryland School of Medicine Center for Vaccine Development
  • John Hopkins University (JHU)
  • Walter Reed National Military Medical Center (WRNMMC)
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
  • Massachusetts General Hospital
  • Brigham and Women's Hospital/Harvard Medical School
  • Brigham and Women's Hospital
  • Boston Med Center
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts Medical School
  • University of Michigan
  • Bronson Healthcare Group
  • Saint Mary's Hospital (Mayo Clinic)
  • Mount Sinai Medical Center
  • Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College
  • Montefiore Medical Center/Albert Einstein College of Medicine
  • University of North Carolina at Chapel Hill
  • University of Cincinnati College of Medicine
  • University Hospitals Case Medical Center
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center (UPMC)
  • Texas Tech University Health Science Center (HSC)- Amarillo
  • Texas Children's Hospital
  • Texas Tech HSC-Lubbock, TX
  • Naval Medical Center Portsmouth
  • Madigan Army Medical Center (MAMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plasma and Standard Care

Standard Care

Arm Description

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

Participants will receive standard care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Normalization of Respiratory Status (All Randomized Participants)
Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.
Duration of Time to Resolution of Clinical Symptoms
The assessed clinical symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Symptoms were assessed at days 0, 1, 2, 4, 7, 14, and 28.
Duration of Time to Resolution of Fever
Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
Duration of Time to Resolution of All Symptoms and Fever
The assessed symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
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
The analysis is restricted to participants >= 18 years old and the SOFA score because there were very few evaluations of the PELOD score during follow-up for the participants < 18 years old. The adult population was further subset to those with a non-missing and non-zero SOFA score at Day 0; those with missing SOFA score at Day 0 did not have a starting point, and those with SOFA = 0 at Day 0 could not have an improvement.
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time
Number of participants with ABG done and no increase of 50 millimeters of mercury (mm/Hg) or greater in PaO2/FiO2 ratio. PaO2/FiO2 ratio was evaluated by an ABG. ABG was performed only when clinically indicated.
In-hospital Mortality
Number of deaths in hospital during initial hospital admission
28-day Mortality
Number of deaths during study follow-up
Duration of Hospitalization
Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Number of ICU Admissions
Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.
Duration of Stay in ICU
Days that a participant spent in ICU. Multiple ICU admissions are summed up.
Days on Supplemental Oxygen
Time (in days) of supplemental oxygen use
Duration of Supplemental Oxygen
Duration of supplemental oxygen use in days
Incidence of Acute Respiratory Distress Syndrome (ARDS) Present
Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.
Days on Mechanical Ventilation
Time (in days) of mechanical ventilation use
Duration of Mechanical Ventilation
Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Disposition Following Initial Hospitalization
Disposition following initial hospitalization was categorized as follows: "released home - home health care not required", " released home with home health care", "transferred to long-term care facility", "hospitalization ongoing at Day 28", "deceased".
Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs
Duration of viral shedding < lower limit of quantification (LLOQ) in nasal swabs (restricted to participants with viral shedding >= LLOQ in nasal swabs at Day 0)
Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women
Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants
Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women
Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants
Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women
Incidence of spontaneous abortion or stillborn fetus for pregnant female participants

Full Information

First Posted
January 16, 2010
Last Updated
August 3, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01052480
Brief Title
Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza
Acronym
IRC002
Official Title
A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Morbidity and mortality occur despite treatment with current antivirals. Circulating influenza H1N1 and H3N2 isolates are highly resistant to amantadine and rimantadine, whereas previous seasonal H1N1 isolates were highly resistant to oseltamivir. So there is concern that circulating influenza A/H1N1 2009 virus may also acquire oseltamivir resistance. This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza. Hospitalized subjects with influenza at risk for severe disease (as defined in the inclusion criteria) will be eligible for study participation. This study will enroll adults, children and pregnant women. Up to 40 sites in the United States will participate in this protocol. One hundred eligible subjects will be randomized in a 1:1 ratio to receive either 2 units (or pediatric equivalent) of anti-influenza immune plasma on Study Day 0 in addition to standard care or standard care alone (50 subjects receiving standard care alone; 50 subjects receiving anti-influenza immune plasma and standard care). Subjects will be assessed on Study Day 0 (pre-dose), 30 minutes post-dose (plasma arm only), and on Study Days 1, 2, 4, 7, 14, and 28. All subjects will undergo a series of efficacy, safety, and PK (HAI) assessments during the study. Blood samples will be collected at each time point (except Day 1). Nasal and oropharyngeal swabs for influenza PCR will be obtained on Days 0,1,2,4 and 7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A, Influenza B
Keywords
Antiviral, Anti-Influenza Immune Plasma, Emerging Infectious Disease, Swine Flu

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plasma and Standard Care
Arm Type
Experimental
Arm Description
Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies (Anti-Influenza Immune Plasma) in addition to standard care.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Participants will receive standard care.
Intervention Type
Biological
Intervention Name(s)
Anti-Influenza Immune Plasma
Intervention Description
2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Intervention Type
Drug
Intervention Name(s)
Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Normalization of Respiratory Status (Primary Efficacy Population)
Description
Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.
Time Frame
Measured from Day 0 through Day 28
Secondary Outcome Measure Information:
Title
Time to Normalization of Respiratory Status (All Randomized Participants)
Description
Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Time to Resolution of Clinical Symptoms
Description
The assessed clinical symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Symptoms were assessed at days 0, 1, 2, 4, 7, 14, and 28.
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Time to Resolution of Fever
Description
Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Time to Resolution of All Symptoms and Fever
Description
The assessed symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
Time Frame
Measured from Day 0 through Day 28
Title
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
Description
The analysis is restricted to participants >= 18 years old and the SOFA score because there were very few evaluations of the PELOD score during follow-up for the participants < 18 years old. The adult population was further subset to those with a non-missing and non-zero SOFA score at Day 0; those with missing SOFA score at Day 0 did not have a starting point, and those with SOFA = 0 at Day 0 could not have an improvement.
Time Frame
Measured from Day 0 through Day 28
Title
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time
Description
Number of participants with ABG done and no increase of 50 millimeters of mercury (mm/Hg) or greater in PaO2/FiO2 ratio. PaO2/FiO2 ratio was evaluated by an ABG. ABG was performed only when clinically indicated.
Time Frame
Measured at Days 1, 2, 4, 7, 14, 28
Title
In-hospital Mortality
Description
Number of deaths in hospital during initial hospital admission
Time Frame
Measured from Day 0 through Day 28
Title
28-day Mortality
Description
Number of deaths during study follow-up
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Hospitalization
Description
Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Time Frame
Measured from Day 0 through Day 28
Title
Number of ICU Admissions
Description
Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Stay in ICU
Description
Days that a participant spent in ICU. Multiple ICU admissions are summed up.
Time Frame
Measured from Day 0 through Day 28
Title
Days on Supplemental Oxygen
Description
Time (in days) of supplemental oxygen use
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Supplemental Oxygen
Description
Duration of supplemental oxygen use in days
Time Frame
Measured from Day 0 through Day 28
Title
Incidence of Acute Respiratory Distress Syndrome (ARDS) Present
Description
Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.
Time Frame
Measured at Days 0, 1, 2, 4, 7, 14, 28
Title
Days on Mechanical Ventilation
Description
Time (in days) of mechanical ventilation use
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Mechanical Ventilation
Description
Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Time Frame
Measured from Day 0 through Day 28
Title
Disposition Following Initial Hospitalization
Description
Disposition following initial hospitalization was categorized as follows: "released home - home health care not required", " released home with home health care", "transferred to long-term care facility", "hospitalization ongoing at Day 28", "deceased".
Time Frame
Measured from Day 0 through Day 28
Title
Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs
Description
Duration of viral shedding < lower limit of quantification (LLOQ) in nasal swabs (restricted to participants with viral shedding >= LLOQ in nasal swabs at Day 0)
Time Frame
Measured from Day 0 through Day 28
Title
Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women
Description
Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants
Time Frame
Measured through to Day 28
Title
Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women
Description
Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants
Time Frame
Measured through Day 28
Title
Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women
Description
Incidence of spontaneous abortion or stillborn fetus for pregnant female participants
Time Frame
Measured from Day 0 through Day 28

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Beigel, MD
Organizational Affiliation
Leidos Biomedical Research, Inc. in support of Laboratory of Immunoregulation, NIAID, NIH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard Davey, MD
Organizational Affiliation
Laboratory of Immunoregulation, NIAID, NIH
Official's Role
Study Chair
Facility Information:
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1752
Country
United States
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Los Angeles Biomedical Research Institute, CA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Children's National Medical Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Washington, DC VA Med Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University (NU)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Maryland School of Medicine Center for Vaccine Development
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
John Hopkins University (JHU)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Walter Reed National Military Medical Center (WRNMMC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital/Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Med Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Bronson Healthcare Group
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Saint Mary's Hospital (Mayo Clinic)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Montefiore Medical Center/Albert Einstein College of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0405
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Texas Tech University Health Science Center (HSC)- Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech HSC-Lubbock, TX
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Facility Name
Madigan Army Medical Center (MAMC)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8903148
Citation
Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
Results Reference
background
PubMed Identifier
1731092
Citation
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.
Results Reference
background
PubMed Identifier
16371632
Citation
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.
Results Reference
background
PubMed Identifier
28522352
Citation
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. Erratum In: Lancet Respir Med. 2017 Jul;5(7):e26.
Results Reference
derived
Links:
URL
https://clinicalstudies.info.nih.gov/detail/B_2010-I-0043.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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