AzTrials
AzTrials

InfluenzaPhase 2IRC003NCT01227967

Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications

A Phase 2 study testing Amantadine, Ribavirin, Oseltamivir and Oseltamivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 91 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

Seasonal influenza is responsible for many hospitalizations and deaths each year, despite effective antiviral treatments. Some individuals have medical conditions such as heart or lung diseases that make them particularly at risk of severe influenza infections that may result in hospitalization or death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza
What is being tested?
Amantadine, Ribavirin, Oseltamivir and Oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
881 participants
Where
91 sitesin 5 countries
Study dates
Sep 2010to 30 Mar 2017
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Enrollment (Screening)
  • Signed informed consent prior to initiation of any study procedures
  • Presence of an underlying medical condition(s) that might increase risk of complications from influenza
  • History of an influenza-like illness defined as:
  • One or more respiratory symptom (cough, sore throat, or nasal symptoms) AND
  • Either
Show all 32Show fewer
  • Fever (subjective or documented >38 degrees C) OR
  • 1 or more constitutional symptom (headache, malaise, myalgia, sweats/chills or fatigue)
  • Onset of illness no more than 96 hours before screening defined as when the subject experienced at least one respiratory symptom, constitutional symptom, or fever
  • Willingness to have samples stored
  • Randomization
  • Signed informed consent
  • Presence of a medical condition(s) that had been associated with increased risk of complications from influenza
  • Age 65 years of age or older
  • Asthma
  • Neurological and neuro-developmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury) [though still able to provide informed consent per inclusion criteria #1]
  • Chronic lung disease (such as COPD and cystic fibrosis)
  • Heart disease (such as congenital heart disease, congestive heart failure, and coronary artery disease)
  • Blood disorders (excluding genetic causes of anemia, as noted in the exclusion criteria)
  • Endocrine disorders (such as diabetes mellitus)
  • Kidney disorders
  • Liver disorders
  • Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
  • Weakened immune system due to disease or medication (such as people with HIV/AIDS, or cancer, chronic steroids or other medications causing immune suppression)
  • BMI ≥ 40(kg/m²)
  • Onset of illness no more than 96 hours before screening defined as when the subject experienced at least one respiratory symptom, constitutional symptom, or fever
  • Positive test for influenza (either rapid antigen or PCR)
  • Results from influenza testing obtained for clinical indications within 12 hours before screening/enrollment may be used if available. Randomization may proceed in cases of discrepant results (one positive and one negative)
  • One of the following to avoid pregnancy:
  • Females who were able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception from the date of informed consent through 6 months after the last dose of study drug. At least one of the methods of contraception should be a barrier method
  • Males who had not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of informed consent through 6 months after the last dose of study drug
  • Willingness to have samples stored

Who cannot join

  • (for Enrollment or Randomization)
  • Women who were pregnant or breast-feeding, and men whose female partner(s) was pregnant
  • Inability to take oral medication or a history of gastrointestinal malabsorption that would preclude the use of oral medication.
  • Hemoglobin < 10 g/dL
  • WBC < 1.5 times 10(9)/L
  • Neutrophils < 0.75 x 10(9)/L
Show all 19Show fewer
  • Platelets < 50 x 10(9)/L
  • History of genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or autoimmune hemolytic anemia
  • Received more than 2 doses of any antiviral influenza medications since onset of influenza symptoms
  • Received stavudine (d4T), didanosine (ddI), zidovudine (AZT), or azathioprine within 30 days prior to study entry
  • Creatinine clearance less than 60 mL/min (estimated by the Cockcroft-Gault equation using serum creatinine)
  • History of autoimmune hepatitis
  • Uncompensated liver disease (defined as AST > 3 times site upper limit of normal (ULN), ALT > 3 times ULN, or Direct Bilirubin > 2 times ULN)
  • Clinical signs of end-stage liver disease including jaundice, coagulopathy, portal hypertension, esophageal varices, ascites, peripheral edema, gastrointestinal bleeding, or encephalopathy
  • Chronic liver disease categorized as Child-Pugh class C (Child-Pugh score 10-15)
  • Known hypersensitivity to rimantadine, amantadine, ribavirin, oseltamivir, peramivir, or zanamivir
  • Received live attenuated virus vaccine (influenza or other) within 3 weeks prior to study entry
  • Use of any investigational drug within 30 days or 5 half-lives (whichever was longer) prior to study entry
  • Participation in other research protocols that would require more than 100 mL of blood to be drawn in any 4-week period that overlaps with this study.

Trial locations and contacts

91 sites in 5 countries.

91 sites in 5 countries

United States69 sites

  • University of Texas Tech Amarillo

    Amarillo, Texas, 79106

  • University of Colorado

    Aurora, Colorado, 80045

  • NIH Clinical Center

    Bethesda, Maryland, 20892

  • Simon Williamson Clinic

    Birmingham, Alabama, 35211

  • Boston Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • West Florissant Internists

    Bridgeton, Missouri, 63044

  • Family Medicine Associates of Texas

    Carrollton, Texas, 75010

  • Centennial - IMMUNOe International Research

    Centennial, Colorado, 80112

  • East Valley Family Physicians

    Chandler, Arizona, 85224

  • University of North Carolina-Chapel Hill

    Chapel Hill, North Carolina, 27514

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Clinical Research Solutions - Dr. Bart

    Columbia, Tennessee, 38401

  • 3rd Coast Research Associates

    Corpus Christi, Texas, 78413

  • WCCT Global LLC

    Costa Mesa, California, 92626

  • Ridge Family Practice

    Council Bluffs, Iowa, 51503

  • Henry Ford Health Systems

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • Clinical Research Advantage/ Skyline Medical Center

    Elkhorn, Nebraska, 68022

  • Horizon Research Group, of Opelousas, LLC

    Eunice, Louisiana, 70535

  • Clinical Research Solutions - Dr. Slandzicki

    Franklin, Tennessee, 37064

  • Prairie Fields Family Medicine

    Fremont, Nebraska, 68025

  • University of Florida

    Gainesville, Florida, 32610

  • Advanced Rx Clinical Research

    Garden Grove, California, 92843

  • Thomas Lenzmeier Family Practice

    Glendale, Arizona, 85308

  • Best Quality Research Inc.

    Hialeah, Florida, 33016

  • University of Texas at Houston

    Houston, Texas, 77030

  • Centex Studies Inc. - Dr. Pouzar

    Houston, Texas, 77062

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77098

  • University of Iowa

    Iowa City, Iowa, 52246

  • Clinical Research Solutions - Dr. Hoppers

    Jackson, Tennessee, 38305

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Centex Studies Inc. - Dr. Seep

    Lake Charles, Louisiana, 70601

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • University of Southern California

    Los Angeles, California, 90033

  • Texas Tech HSC

    Lubbock, Texas, 79430

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33015

  • Medical Consulting Center

    Miami, Florida, 33125

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • University of Miami

    Miami, Florida, 33136

  • Clinical Research Solutions - Dr. Panuto

    Middleburg Heights, Ohio, 44130

  • Clinical Research Solutions - Dr. Rowe

    Nashville, Tennessee, 37211

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • New Jersey Medical School

    Newark, New Jersey, 07103

  • Sneeze, Wheeze & Itch Associates, LLC

    Normal, Illinois, 61761

  • Southwest Family Physicians

    Omaha, Nebraska, 68124

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • Centex Studies Inc. - Dr. Garcia

    Pharr, Texas, 78577

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Central Phoenix Medical Center

    Phoenix, Arizona, 85020

  • DMI Research, Inc.

    Pinellas Park, Florida, 33782

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Village Health Partners

    Plano, Texas, 75024

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Endeavor Clinical Trials

    San Antonio, Texas, 78229

  • Bandera Family Healthcare Research

    San Antonio, Texas, 78249

  • University of California at San Diego

    San Diego, California, 92103

  • Montgomery Medical

    Smithfield, Pennsylvania, 15478

  • Clinical Research Solutions - Dr. Dar

    Smyrna, Tennessee, 37167

  • James J. Peters, VA Medical Center

    The Bronx, New York, 10468

  • Westlake Medical Research (CA)

    Thousand Oaks, California, 91360

  • Los Angeles BioMedical Research Institute

    Torrance, California, 90502

  • Empire Clinical Research

    Upland, California, 91786

  • UMass Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Argentina8 sites

  • Centro de Educación Médica e Investigaciónes Clínicas (CEMIC)

    Buenos Aires

  • Fundación del Centro de Estudios Infectológicos (FUNCEI)

    Buenos Aires

  • Hospital General de Agudos J. M. Ramos Mejía

    Buenos Aires

  • Hospital Italiano de Buenos Aires

    Buenos Aires

  • Hospital Rawson

    Córdoba

  • Instituto Medico Platense

    La Plata, Buenos Aires

  • Instituto Centralizado de Asistencia e Investigación Clínica Integral (CAICI)

    Santa Fe

  • Hospital Houssay

    Vicente López, Buenos Aires

Other trials in Argentina

Australia7 sites

  • Holdsworth House Med Practice

    Darlinghurst, New South Wales, 2010

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales, 2010

  • Northside Clinic

    Fitzroy North, Victoria, 3068

  • Royal Brisbane

    Herston, Queensland, 4029

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052

  • Westmead Hospital

    Westmead, New South Wales

Other trials in Australia

Thailand4 sites

  • Siriraj Hospital, Mahidol University

    Bangkoknoi, Bangkok, 10700

  • Srinagarind Hospital, Khon Kaen University

    Muang, Changwat Khon Kaen, 40002

  • Bamrasnaradura Infectious Diseases Institute

    Muang, Changwat Nonthaburi, 11000

  • HIV-NAT, The Thai Red Cross AIDS

    Patumwan, Bangkok, 10330

Other trials in Thailand

Mexico3 sites

  • Instituto Nacional de Ciencias Médicas y Nutrición (INCMN) Salvador Zubirán

    México

  • Hospital General y de Alta Especialidad "Dr. Manuel GEA Gonzalez"

    Tlalpan

  • Instituto Nacional de Enfermedades Respiratorias (INER)

    Tlalpan

Other trials in Mexico

About this study

Official title: A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications

Seasonal influenza is responsible for many hospitalizations and deaths each year, despite effective antiviral treatments. Some individuals have medical conditions such as heart or lung diseases that make them particularly at risk of severe influenza infections that may result in hospitalization or death. Oseltamivir (Tamiflu) is used most often to treat flu, but there are still many hospitalizations, complications, and deaths even with treatment. This study evaluated the use of combination antivirals (amantadine, oseltamivir, and ribavirin) compared to oseltamivir alone in the treatment of influenza in an at-risk population.

Read the detailed description

Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually and despite effective antivirals causes significant morbidity and mortality (estimated 24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S) but in contrast to seasonal flu, nearly 90 percent of the deaths with the 2009 H1N1 occurred among people younger than 65 years of age. The CDC has defined an at-risk population that accounts for the majority of hospitalization and morbidity associated with influenza. This study evaluated the use of combination antivirals as compared to oseltamivir alone in the treatment of influenza in an at-risk population.

Subjects who met the CDC definition for being at-risk and that present with an influenza-like illness were screened for the study. Those subjects with a confirmatory test for influenza (rapid antigen or PCR) were randomized in a 1:1 manner to receive a blinded study treatment consisting of either the combination of amantadine, oseltamivir, and ribavirin or oseltamivir alone for 5 days. Clinical, virologic, and laboratory assessments on Days 1, 3, 7, 14, and 28 were used for both safety and efficacy analysis.

Design:

  • Participants were screened with a physical examination and medical history, along with blood tests and throat swabs to confirm influenza infection.
  • Eligible participants were randomly assigned to take either oseltamivir alone (the current standard treatment for influenza) or to take oseltamivir, amantadine, and ribavirin. Participants had additional blood samples and throat swabs taken at the start of the study, and were shown how to complete a study diary at home.
  • Participants received a study medication kit containing the medication to take at home twice a day for 5 days.
  • Participants returned, with the medication kit, to the clinic on days 1 (the first day after the start of the study), 3, 7, 14, and 28. The first visit took 2 to 3 hours, but each subsequent visit took approximately 1 to 2 hours. Additional blood samples and throat swabs were taken at these visits.

Pilot study:

Due to the lack of reliable data concerning the AUC virologic endpoint, an "external" pilot study was conducted in the first 47 patients randomized to identify a primary endpoint and method of analysis, and to possibly modify the sample size. To ensure no effect on the type I error rate, data from these 47 patients were excluded from the primary and secondary efficacy analyses but were used in other analyses of secondary objectives.

Conditions
Influenza
Being tested
Amantadine, Ribavirin, Oseltamivir, Oseltamivir
Keywords
Adaptive Design, At Risk, H1N1, Synergy, TCAD
Medical subject headings
Influenza, Human

What participants receive

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

  • Amantadine, Ribavirin, OseltamivirDrug

    Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.

  • OseltamivirDrug

    Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.

Study groups in NCT01227967
Study groupRoleWhat they receive
Combination TherapyExperimentalAmantadine, Ribavirin, Oseltamivir
Receives: Drug: Amantadine, Ribavirin, Oseltamivir
Oseltamivir monotherapyActive comparatorOseltamivir
Receives: Drug: Oseltamivir

What is being measured

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

  1. Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs

    The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.

    Measured: At Day 3

Secondary outcomes (14)

  1. Number of Participants by Virus Detection Status

    Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ

    Measured: At Day 0, 3 and 7.

  2. qPCR Viral Shedding

    Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.)

    Measured: At Day 0, 3 and 7

  3. Number of Participants Shedding Virus

    Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).

    Measured: At day 3 and 7.

  4. Time to Alleviation of Influenza Clinical Symptoms.

    The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.

    Measured: From treatment initiation to Day 28

  5. Time to Absence of Fever

    Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.

    Measured: From treatment initiation to Day 28

  6. Time to Resolution of All Symptoms AND Fever

    The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.

    Measured: From treatment initiation to Day 28

  7. Time to Feeling as Good as Before the Onset of the Influenza Illness

    Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.

    Measured: From treatment initiation to Day 28

  8. Time to Return to Pre-influenza Function

    Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.

    Measured: From treatment initiation to Day 28

  9. Time to Return of Physical Function to Pre-illness Leve

    Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.

    Measured: From treatment initiation to Day 28

  10. Percentage of Participants With Clinical Failure at Day 5

    Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5.

    Measured: From treatment initiation to Day 28

  11. Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.

    Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.

    Measured: From treatment initiation to Day 28

  12. Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen

    Percentage of participants who required new or increased use of supplemental oxygen

    Measured: From treatment initiation to Day 28

  13. Percentage of Participants Who Required Hospitalization.

    The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves.

    Measured: From treatment initiation to Day 28

  14. 28-day Mortality

    Number of deaths

    Measured: From treatment initiation to Day 28

Timeline

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

  1. First posted25 Oct 2010 (estimated)
  2. Study startSep 2010
  3. Primary completion2 May 2016
  4. Study completion30 Mar 2017

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01227967
Sponsor's protocol ID
10-I-0210
Other IDs
10-I-0210, IRC003
Acronym
IRC003
Status last verified
Jan 2019
First submitted
22 Oct 2010
Last updated
4 Feb 2019
Data monitoring committee
Yes

Publications

  • Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.

    PubMed 12517228

  • Monto AS. Vaccines and antiviral drugs in pandemic preparedness. Emerg Infect Dis. 2006 Jan;12(1):55-60. doi: 10.3201/eid1201.051068.

    PubMed 16494718

  • Moscona A. Oseltamivir resistance--disabling our influenza defenses. N Engl J Med. 2005 Dec 22;353(25):2633-6. doi: 10.1056/NEJMp058291. No abstract available.

    PubMed 16371626

  • Beigel JH, Bao Y, Beeler J, Manosuthi W, Slandzicki A, Dar SM, Panuto J, Beasley RL, Perez-Patrigeon S, Suwanpimolkul G, Losso MH, McClure N, Bozzolo DR, Myers C, Holley HP Jr, Hoopes J, Lane HC, Hughes MD, Davey RT; IRC003 Study Team. Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial. Lancet Infect Dis. 2017 Dec;17(12):1255-1265. doi: 10.1016/S1473-3099(17)30476-0. Epub 2017 Sep 22.

    PubMed 28958678

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amantadine, Ribavirin, Oseltamivir and Oseltamivir in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 91 sites in 5 countries.

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 32 inclusion and 19 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Argentina, Australia, Thailand, Mexico. 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 11 Jul 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?

Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs (time frame: At Day 3). 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 NCT01227967, 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 4 Feb 2019.

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