Influenza APhase 2IRC002NCT01052480

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

A Phase 2 study testing Anti-Influenza Immune Plasma in people with Influenza A and Influenza B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Influenza A, Influenza B
What is being tested?: Anti-Influenza Immune Plasma
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 35 sitesUnited States
Study dates: Dec 2010to Nov 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Texas Tech University Health Science Center (HSC)- Amarillo
Amarillo, Texas, 79106
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
University of Maryland School of Medicine Center for Vaccine Development
Baltimore, Maryland, 21201
John Hopkins University (JHU)
Baltimore, Maryland, 21218
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, 20889
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital/Harvard Medical School
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Med Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University (NU)
Chicago, Illinois, 60611
The Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267-0405
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
University of Florida
Gainesville, Florida, 32608
Texas Children's Hospital
Houston, Texas, 77030
Bronson Healthcare Group
Kalamazoo, Michigan, 49007
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-1752
Texas Tech HSC-Lubbock, TX
Lubbock, Texas, 79430
Mount Sinai Medical Center
New York, New York, 10029
Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, 10065
Montefiore Medical Center/Albert Einstein College of Medicine
New York, New York, 10467
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Saint Mary's Hospital (Mayo Clinic)
Rochester, Minnesota, 55905
Naval Medical Center San Diego
San Diego, California, 92134
Madigan Army Medical Center (MAMC)
Tacoma, Washington, 98431
Los Angeles Biomedical Research Institute, CA
Torrance, California, 90502
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Washington, DC VA Med Center
Washington D.C., District of Columbia, 20422
University of Massachusetts Medical School
Worcester, Massachusetts, 01655

Other trials in United States

About this study

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)

Read the 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.

Conditions: Influenza A, Influenza B
Being tested: Anti-Influenza Immune Plasma, Standard Care
Keywords: Antiviral, Anti-Influenza Immune Plasma, Emerging Infectious Disease, Swine Flu
Medical subject headings: Communicable Diseases, Emerging, Orthomyxoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti-Influenza Immune PlasmaBiological
2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Standard CareDrug
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.

Study groups in NCT01052480
Study group	Role	What they receive
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. Receives: Biological: Anti-Influenza Immune Plasma; Drug: Standard Care
Standard Care	Active comparator	Participants will receive standard care. Receives: Drug: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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: Measured from Day 0 through Day 28

Secondary outcomes (21)

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.
Measured: Measured from Day 0 through Day 28
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.
Measured: Measured from Day 0 through Day 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.
Measured: Measured from Day 0 through Day 28
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.
Measured: 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
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.
Measured: Measured from Day 0 through Day 28
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.
Measured: Measured at Days 1, 2, 4, 7, 14, 28
In-hospital Mortality
Number of deaths in hospital during initial hospital admission
Measured: Measured from Day 0 through Day 28
28-day Mortality
Number of deaths during study follow-up
Measured: Measured from Day 0 through Day 28
Duration of Hospitalization
Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Measured: Measured from Day 0 through Day 28
Number of ICU Admissions
Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.
Measured: Measured from Day 0 through Day 28
Duration of Stay in ICU
Days that a participant spent in ICU. Multiple ICU admissions are summed up.
Measured: Measured from Day 0 through Day 28
Days on Supplemental Oxygen
Time (in days) of supplemental oxygen use
Measured: Measured from Day 0 through Day 28
Duration of Supplemental Oxygen
Duration of supplemental oxygen use in days
Measured: Measured from Day 0 through Day 28
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.
Measured: Measured at Days 0, 1, 2, 4, 7, 14, 28
Days on Mechanical Ventilation
Time (in days) of mechanical ventilation use
Measured: Measured from Day 0 through Day 28
Duration of Mechanical Ventilation
Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Measured: Measured from Day 0 through Day 28
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".
Measured: Measured from Day 0 through Day 28
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)
Measured: Measured from Day 0 through Day 28
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
Measured: Measured through to Day 28
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
Measured: Measured through Day 28
Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women
Incidence of spontaneous abortion or stillborn fetus for pregnant female participants
Measured: Measured from Day 0 through Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Nov 2015

First posted20 Jan 2010 (estimated)
Study startDec 2010
Primary completionMar 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Influenza AStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01052480
Sponsor's protocol ID: 10-I-0043
Other IDs: IRC002
Acronym: IRC002
Status last verified: Jun 2017
First submitted: 16 Jan 2010
Last updated: 5 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
PubMed 8903148
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.
PubMed 1731092
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.
PubMed 16371632
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.
PubMed 28522352

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy Participants

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01052480
Acronym / sponsor ID: IRC002 / 10-I-0043
Conditions: Influenza A, Influenza B
Keywords: Antiviral, Anti-Influenza Immune Plasma, Emerging Infectious Disease, Swine Flu
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: Dec 2010 (actual)
Primary completion: Mar 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 20 Jan 2010 (estimated)
Results: Posted 23 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Plasma and Standard Care	Experimental	Biological: Anti-Influenza Immune Plasma, Drug: Standard CareParticipants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies (Anti-Influenza Immune Plasma) in addition to standard care.
Standard Care	Active comparator	Drug: Standard CareParticipants will receive standard care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anti-Influenza Immune Plasma2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline	Biological	Plasma and Standard Care
Standard CareAll 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.	Drug	Plasma and Standard Care, Standard Care

Primary outcome

Time to Normalization of Respiratory Status (Primary Efficacy Population)
Time frame: Measured from Day 0 through Day 28
Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.

21 secondary outcomes

Time to Normalization of Respiratory Status (All Randomized Participants)
Time frame: Measured from Day 0 through Day 28
Duration of Time to Resolution of Clinical Symptoms
Time frame: Measured from Day 0 through Day 28
Duration of Time to Resolution of Fever
Time frame: Measured from Day 0 through Day 28
Duration of Time to Resolution of All Symptoms and Fever
Time frame: 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
Time frame: Measured from Day 0 through Day 28
50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time
Time frame: Measured at Days 1, 2, 4, 7, 14, 28
In-hospital Mortality
Time frame: Measured from Day 0 through Day 28
28-day Mortality
Time frame: Measured from Day 0 through Day 28
Duration of Hospitalization
Time frame: Measured from Day 0 through Day 28
Number of ICU Admissions
Time frame: Measured from Day 0 through Day 28
Duration of Stay in ICU
Time frame: Measured from Day 0 through Day 28
Days on Supplemental Oxygen
Time frame: Measured from Day 0 through Day 28
Duration of Supplemental Oxygen
Time frame: Measured from Day 0 through Day 28
Incidence of Acute Respiratory Distress Syndrome (ARDS) Present
Time frame: Measured at Days 0, 1, 2, 4, 7, 14, 28
Days on Mechanical Ventilation
Time frame: Measured from Day 0 through Day 28
Duration of Mechanical Ventilation
Time frame: Measured from Day 0 through Day 28
Disposition Following Initial Hospitalization
Time frame: Measured from Day 0 through Day 28
Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs
Time frame: Measured from Day 0 through Day 28
Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women
Time frame: Measured through to Day 28
Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women
Time frame: Measured through Day 28
Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women
Time frame: Measured from Day 0 through Day 28

Results and safety

Results posted to the registry on 23 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Plasma and Standard Care	49	41
Standard Care	49	32

Primary outcome: Time to Normalization of Respiratory Status (Primary Efficacy Population)

Time frame: Measured from Day 0 through Day 28. Median (Inter-Quartile Range). Unit: days

Measure	Plasma and Standard Care n = 42	Standard Care n = 45
Value	7 (2 to NA)	28 (7 to NA)

Plasma and Standard Care vs Standard Care: p = 0.069, Log Rank

Population analysed: The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Plasma and Standard Care	9 of 46 (19.6%)	36 of 46 (78.3%)	1 of 49
Standard Care	20 of 52 (38.5%)	29 of 52 (55.8%)	5 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8903148Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
Background: PubMed 1731092Bean 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.
Background: PubMed 16371632de 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.
Derived from this study: PubMed 28522352Beigel 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.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.

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Healthy Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Beigel, MD study chair

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

Richard Davey, MD study chair

Laboratory of Immunoregulation, NIAID, NIH

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-Influenza Immune Plasma in people with Influenza A and Influenza B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Normalization of Respiratory Status (Primary Efficacy Population) (time frame: Measured from Day 0 through Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01052480, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.