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Trial record 1 of 1 for:    NCT01227967
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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 (IRC003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01227967
First received: October 22, 2010
Last updated: July 10, 2017
Last verified: July 2017
Results First Received: May 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Influenza
Interventions: Drug: Amantadine, Ribavirin, Oseltamivir
Drug: Oseltamivir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Outpatient or hospitalized participants at high risk for complications and morbidity, diagnosed with influenza by rapid antigen or PCR were recruited at 65 sites from 5 countries: 52 from the U.S., 2 from Australia, 3 from Mexico, and 4 each in Thailand and Argentina, between March 2011 to April 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eight hundred eighty-one subjects were enrolled per protocol (signed consent). Two hundred fifty-one subjects were excluded during screening and did not participate in any other aspect of the trial. Three subjects were randomized improperly because they were given study drug kit prior to the randomization.

Reporting Groups
  Description
Combination Therapy

Drug: Amantadine, Ribavirin, Oseltamivir

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.

Oseltamivir Monotherapy

Drug: Oseltamivir

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


Participant Flow:   Overall Study
    Combination Therapy   Oseltamivir Monotherapy
STARTED   314   316 
COMPLETED [1]   298   303 
NOT COMPLETED   16   13 
Protocol Violation                3                1 
Death                0                1 
Lost to Follow-up                8                3 
Withdrawal by Subject                4                3 
Physician Decision                0                1 
Never Started Treatment                0                4 
Taking Additional Antiviral Drug                1                0 
[1] Results were through database cutoff (10 November 2016) for efficacy analysis (through Day 28 visit)



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent To Treat (ITT) Population: all participants who were randomized properly and who had received at least one dose of study drug.

Reporting Groups
  Description
Combination Therapy

Drug: Amantadine, Ribavirin, Oseltamivir

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.

Oseltamivir Monotherapy

Drug: Oseltamivir

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

Total Total of all reporting groups

Baseline Measures
   Combination Therapy   Oseltamivir Monotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 314   312   626 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
<=18 years      1   0.3%      4   1.3%      5   0.8% 
Between 18 and 65 years      252  80.3%      241  77.2%      493  78.8% 
>=65 years      61  19.4%      67  21.5%      128  20.4% 
Age 
[Units: Years]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
   49.5 
 (37 to 61) 
 49.5 
 (35.5 to 61) 
 49.5 
 (36 to 61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
Female      187  59.6%      198  63.5%      385  61.5% 
Male      127  40.4%      114  36.5%      241  38.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
Hispanic or Latino      55  17.5%      58  18.6%      113  18.1% 
Not Hispanic or Latino      258  82.2%      254  81.4%      512  81.8% 
Unknown or Not Reported      1   0.3%      0   0.0%      1   0.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
White      203  64.6%      189  60.6%      392  62.6% 
Asian      70  22.3%      73  23.4%      143  22.8% 
Black or African American      18   5.7%      25   8.0%      43   6.9% 
American Indian      1   0.3%      2   0.6%      3   0.5% 
Race not available to clinic      21   6.7%      21   6.7%      42   6.7% 
Subject does not want to report      1   0.3%      1   0.3%      2   0.3% 
Subject does not know      0   0.0%      1   0.3%      1   0.2% 
Region of Enrollment 
[Units: Participants]
     
Argentina       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Argentina   12   10   22 
United States       
Participants Analyzed 
[Units: Participants]
 314   312   626 
United States   220   216   436 
Mexico       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Mexico   17   18   35 
Australia       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Australia   0   2   2 
Thailand       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Thailand   65   66   131 
Influenza Diagnostic Test by Local Testing 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
RT-PCR/PCR      33  10.5%      30   9.6%      63  10.1% 
Rapid antigen test      281  89.5%      281  90.1%      562  89.8% 
Isothermal nucleic acid amplification technology      0   0.0%      1   0.3%      1   0.2% 
Positive Influenza Test by Local Testing 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
   314   312   626 
Result of Influenza Test By Local Testing 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
Influenza A/H1N1      13   4.1%      14   4.5%      27   4.3% 
Influenza A/H3N2      1   0.3%      1   0.3%      2   0.3% 
Influenza A unsubtypable      29   9.2%      22   7.1%      51   8.1% 
Influenza A not typed      180  57.3%      180  57.7%      360  57.5% 
Influenza B      75  23.9%      80  25.6%      155  24.8% 
Influenza positive (unknown A or B)      10   3.2%      5   1.6%      15   2.4% 
Multiple types/subtypes      6   1.9%      10   3.2%      16   2.6% 
Confirmed Influenza Infection Status By Central Testing 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      230  73.2%      224  71.8%      454  72.5% 
No      84  26.8%      88  28.2%      172  27.5% 
Influenza Type/Subtype By Central Testing [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
Influenza A/H3N2      126  40.1%      118  37.8%      244  39.0% 
Influenza A/H1N1      55  17.5%      49  15.7%      104  16.6% 
Influenza B      49  15.6%      57  18.3%      106  16.9% 
Negative      83  26.4%      86  27.6%      169  27.0% 
Missing      1   0.3%      2   0.6%      3   0.5% 
[1] Influenza type/subtype by central lab testing was from site-collected swab on Day 0 (the first one if more than one was collected) and if that was missing, then from a Day -1 sample, if collected
Quantitative PCR Viral Shedding [1] [2] 
[Units: Log10 copies/mL]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 230   224   454 
   6.4 
 (5.6 to 7.2) 
 6.7 
 (5.1 to 7.7) 
 6.5 
 (5.4 to 7.4) 
[1]

Limit of detection (LOD)/lower limit of quantification (LLOQ) for Flu A and Flu B by qPCR is 3.2/3.9 and 3.4/4.0, respectively.

Results <LOD were imputed as LOD; results >=LOD and <LLOQ were imputed as LLOQ, and results >ULOQ were imputed as ULOQ

[2] The results are for the 454 participants with a confirmed positive test for influenza on a Day 0 sample from the central laboratory using a RT-PCR for influenza type and subtype.
Presence of fever 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      94  29.9%      93  29.8%      187  29.9% 
No      216  68.8%      216  69.2%      432  69.0% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Symptom Score [1] 
[Units: Participants]
Count of Participants
     
Cough       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      18   5.7%      14   4.5%      32   5.1% 
Mild      68  21.7%      86  27.6%      154  24.6% 
Moderate      139  44.3%      130  41.7%      269  43.0% 
Severe      85  27.1%      78  25.0%      163  26.0% 
Missing      4   1.3%      4   1.3%      8   1.3% 
Fatigue       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      28   8.9%      15   4.8%      43   6.9% 
Mild      33  10.5%      43  13.8%      76  12.1% 
Moderate      117  37.3%      105  33.7%      222  35.5% 
Severe      132  42.0%      145  46.5%      277  44.2% 
Missing      4   1.3%      4   1.3%      8   1.3% 
Feverishness       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      70  22.3%      62  19.9%      132  21.1% 
Mild      61  19.4%      68  21.8%      129  20.6% 
Moderate      111  35.4%      98  31.4%      209  33.4% 
Severe      68  21.7%      80  25.6%      148  23.6% 
Missing      4   1.3%      4   1.3%      8   1.3% 
Diarrhea       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      231  73.6%      253  81.1%      484  77.3% 
Mild      36  11.5%      26   8.3%      62   9.9% 
Moderate      26   8.3%      20   6.4%      46   7.3% 
Severe      15   4.8%      10   3.2%      25   4.0% 
Missing      6   1.9%      3   1.0%      9   1.4% 
Muscle aches       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      44  14.0%      30   9.6%      74  11.8% 
Mild      51  16.2%      56  17.9%      107  17.1% 
Moderate      100  31.8%      99  31.7%      199  31.8% 
Severe      115  36.6%      124  39.7%      239  38.2% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Vomiting       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      268  85.4%      269  86.2%      537  85.8% 
Mild      18   5.7%      18   5.8%      36   5.8% 
Moderate      16   5.1%      12   3.8%      28   4.5% 
Severe      6   1.9%      9   2.9%      15   2.4% 
Missing      6   1.9%      4   1.3%      10   1.6% 
Headache       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      60  19.1%      55  17.6%      115  18.4% 
Mild      76  24.2%      81  26.0%      157  25.1% 
Moderate      99  31.5%      99  31.7%      198  31.6% 
Severe      75  23.9%      74  23.7%      149  23.8% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Nausea       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      197  62.7%      198  63.5%      395  63.1% 
Mild      54  17.2%      51  16.3%      105  16.8% 
Moderate      38  12.1%      35  11.2%      73  11.7% 
Severe      19   6.1%      24   7.7%      43   6.9% 
Missing      6   1.9%      4   1.3%      10   1.6% 
Sore throat       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      80  25.5%      80  25.6%      160  25.6% 
Mild      94  29.9%      91  29.2%      185  29.6% 
Moderate      102  32.5%      91  29.2%      193  30.8% 
Severe      34  10.8%      47  15.1%      81  12.9% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Stuffy nose       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      82  26.1%      66  21.2%      148  23.6% 
Mild      62  19.7%      68  21.8%      130  20.8% 
Moderate      107  34.1%      96  30.8%      203  32.4% 
Severe      59  18.8%      78  25.0%      137  21.9% 
Missing      4   1.3%      4   1.3%      8   1.3% 
Rhinorrhea       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Absent      77  24.5%      54  17.3%      131  20.9% 
Mild      79  25.2%      96  30.8%      175  28.0% 
Moderate      96  30.6%      84  26.9%      180  28.8% 
Severe      56  17.8%      74  23.7%      130  20.8% 
Missing      6   1.9%      4   1.3%      10   1.6% 
[1] Symptoms were scored on a 4-point scale : 0=absent, 1=mild, 2=moderate, 3=severe
Overall Symptom Score [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
   15 
 (11 to 19) 
 15 
 (11 to 19) 
 15 
 (11 to 19) 
[1] Overall symptom score was the sum of available scores for each of the 11 symptoms assessed (so ignoring missing values). The possible range of the overall symptom score is therefore 0 (no symptoms) to 44 (severe for all 10 symptoms). Participants with missing evaluations for all symptoms were given a missing overall symptom score.
Functional status 
[Units: Participants]
Count of Participants
     
Vigorous activities       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      238  75.8%      238  76.3%      476  76.0% 
Limited a little = 50      58  18.5%      59  18.9%      117  18.7% 
Not limited at all = 100      14   4.5%      12   3.8%      26   4.2% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Moderate activities       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      167  53.2%      171  54.8%      338  54.0% 
Limited a little = 50      114  36.3%      107  34.3%      221  35.3% 
Not limited at all = 100      29   9.2%      31   9.9%      60   9.6% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Lifting groceries       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      99  31.5%      116  37.2%      215  34.3% 
Limited a little = 50      129  41.1%      114  36.5%      243  38.8% 
Not limited at all = 100      82  26.1%      79  25.3%      161  25.7% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Climbing stairs       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      182  58.0%      172  55.1%      354  56.5% 
Limited a little = 50      97  30.9%      105  33.7%      202  32.3% 
Not limited at all = 100      31   9.9%      32  10.3%      63  10.1% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Climbing 1 flight       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      97  30.9%      103  33.0%      200  31.9% 
Limited a little = 50      146  46.5%      129  41.3%      275  43.9% 
Not limited at all = 100      67  21.3%      77  24.7%      144  23.0% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Bending or kneeling       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      89  28.3%      82  26.3%      171  27.3% 
Limited a little = 50      118  37.6%      133  42.6%      251  40.1% 
Not limited at all = 100      103  32.8%      94  30.1%      197  31.5% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Walking > 1 mile       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      199  63.4%      202  64.7%      401  64.1% 
Limited a little = 50      81  25.8%      78  25.0%      159  25.4% 
Not limited at all = 100      30   9.6%      29   9.3%      59   9.4% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Walking blocks       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      169  53.8%      177  56.7%      346  55.3% 
Limited a little = 50      100  31.8%      91  29.2%      191  30.5% 
Not limited at all = 100      41  13.1%      41  13.1%      82  13.1% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Walking a block       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      101  32.2%      108  34.6%      209  33.4% 
Limited a little = 50      123  39.2%      111  35.6%      234  37.4% 
Not limited at all = 100      86  27.4%      90  28.8%      176  28.1% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Bathing/dressing self       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Limited a lot = 0      48  15.3%      54  17.3%      102  16.3% 
Limited a little = 50      72  22.9%      83  26.6%      155  24.8% 
Not limited at all = 100      190  60.5%      172  55.1%      362  57.8% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Average Functional Status [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 314   312   626 
   35 
 (20 to 60) 
 35 
 (15 to 55) 
 35 
 (15 to 60) 
[1] Average functional status was calculated as the average of the ten items assessed (so ignoring missing values), scoring 0='yes, limited a lot', 50='yes, limited a little', 100='no, not limited at all'. The possible range of the functional status score is therefore 0 (worst possible status) to 100 (best possible status). Participants with missing evaluations for all items were given a missing average functional status.
Global assessment 
[Units: Participants]
Count of Participants
     
Subject feels as good today as before flu       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      9   2.9%      7   2.2%      16   2.6% 
No      301  95.9%      302  96.8%      603  96.3% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Subject functions as well today as before flu       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      23   7.3%      20   6.4%      43   6.9% 
No      287  91.4%      289  92.6%      576  92.0% 
Missing      4   1.3%      3   1.0%      7   1.1% 
Complications of Influenza 
[Units: Participants]
Count of Participants
     
Sinusitis       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      11   3.5%      14   4.5%      25   4.0% 
No      298  94.9%      298  95.5%      596  95.2% 
Unable to assess      2   0.6%      0   0.0%      2   0.3% 
Missing      3   1.0%      0   0.0%      3   0.5% 
Otitis Media       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      2   0.6%      4   1.3%      6   1.0% 
No      307  97.8%      308  98.7%      615  98.2% 
Unable to assess      2   0.6%      0   0.0%      2   0.3% 
Missing      3   1.0%      0   0.0%      3   0.5% 
Bronchitis/Bronchiolitis       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      8   2.5%      14   4.5%      22   3.5% 
No      301  95.9%      298  95.5%      599  95.7% 
Unable to assess      2   0.6%      0   0.0%      2   0.3% 
Missing      3   1.0%      0   0.0%      3   0.5% 
Pneumonia       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      5   1.6%      9   2.9%      14   2.2% 
No      304  96.8%      303  97.1%      607  97.0% 
Unable to assess      2   0.6%      0   0.0%      2   0.3% 
Missing      3   1.0%      0   0.0%      3   0.5% 
Using antibiotic for other reasons       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      20   6.4%      21   6.7%      41   6.5% 
No      291  92.7%      291  93.3%      582  93.0% 
Unable to assess      0   0.0%      0   0.0%      0   0.0% 
Missing      3   1.0%      0   0.0%      3   0.5% 
Medical Conditions [1] 
[Units: Participants]
Count of Participants
     
>= 65 years       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      251  79.9%      247  79.2%      498  79.6% 
No      63  20.1%      65  20.8%      128  20.4% 
Asthma       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      214  68.2%      213  68.3%      427  68.2% 
No      100  31.8%      99  31.7%      199  31.8% 
Neurological condition       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      297  94.6%      293  93.9%      590  94.2% 
No      17   5.4%      19   6.1%      36   5.8% 
Chronic Lung disease       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      297  94.6%      291  93.3%      588  93.9% 
No      17   5.4%      21   6.7%      38   6.1% 
Heart disease       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      284  90.4%      273  87.5%      557  89.0% 
No      30   9.6%      39  12.5%      69  11.0% 
Blood disorder       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      306  97.5%      307  98.4%      613  97.9% 
No      8   2.5%      5   1.6%      13   2.1% 
Endocrine       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      227  72.3%      224  71.8%      451  72.0% 
No      87  27.7%      88  28.2%      175  28.0% 
Kidney       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      306  97.5%      306  98.1%      612  97.8% 
No      8   2.5%      6   1.9%      14   2.2% 
Liver disorder       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      311  99.0%      305  97.8%      616  98.4% 
No      3   1.0%      7   2.2%      10   1.6% 
Metabolic       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      302  96.2%      304  97.4%      606  96.8% 
No      12   3.8%      8   2.6%      20   3.2% 
Weakened immune system       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      270  86.0%      266  85.3%      536  85.6% 
No      44  14.0%      46  14.7%      90  14.4% 
BMI >= 40       
Participants Analyzed 
[Units: Participants]
 314   312   626 
Yes      240  76.4%      261  83.7%      501  80.0% 
No      74  23.6%      51  16.3%      125  20.0% 
[1] Medication conditions that may increase risk of complications from influenza which are used to determine eligibility for the study.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs   [ Time Frame: At Day 3 ]

2.  Secondary:   Number of Participants by Virus Detection Status   [ Time Frame: At Day 0, 3 and 7. ]

3.  Secondary:   qPCR Viral Shedding   [ Time Frame: At Day 0, 3 and 7 ]

4.  Secondary:   Number of Participants Shedding Virus   [ Time Frame: At day 3 and 7. ]

5.  Secondary:   Time to Alleviation of Influenza Clinical Symptoms.   [ Time Frame: From treatment initiation to Day 28 ]

6.  Secondary:   Time to Absence of Fever   [ Time Frame: From treatment initiation to Day 28 ]

7.  Secondary:   Time to Resolution of All Symptoms AND Fever   [ Time Frame: From treatment initiation to Day 28 ]

8.  Secondary:   Time to Feeling as Good as Before the Onset of the Influenza Illness   [ Time Frame: From treatment initiation to Day 28 ]

9.  Secondary:   Time to Return to Pre-influenza Function   [ Time Frame: From treatment initiation to Day 28 ]

10.  Secondary:   Time to Return of Physical Function to Pre-illness Leve   [ Time Frame: From treatment initiation to Day 28 ]

11.  Secondary:   Percentage of Participants With Clinical Failure at Day 5   [ Time Frame: From treatment initiation to Day 28 ]

12.  Secondary:   Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.   [ Time Frame: From treatment initiation to Day 28 ]

13.  Secondary:   Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen   [ Time Frame: From treatment initiation to Day 28 ]

14.  Secondary:   Percentage of Participants Who Required Hospitalization.   [ Time Frame: From treatment initiation to Day 28 ]

15.  Secondary:   28-day Mortality   [ Time Frame: From treatment initiation to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Beigel, M.D.
Organization: Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)
phone: 301-451-9881
e-mail: jbeigel@niaid.nih.gov


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01227967     History of Changes
Other Study ID Numbers: 10-I-0210
IRC003
Study First Received: October 22, 2010
Results First Received: May 31, 2017
Last Updated: July 10, 2017