An interventional study of Oseltamivir and Placebo in Influenza, Human, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 51 sites in 3 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Treatment
People who are infected with the influenza virus may develop respiratory illnesses, such as pneumonia, or other life-threatening complications. Currently, there are four antiviral medications that are used to treat influenza. This study will examine one of these medications, oseltamivir, to examine how it affects the shedding of influenza virus in infected people.
Seasonal influenza is responsible for excess hospitalizations and, despite effective antivirals, causes significant morbidity and mortality (about 24,000 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% of the deaths with the 2009 H1N1 occurred among people younger than 65 years of age. Although there are four currently licensed anti-influenza medications (amantadine and rimantadine, oseltamivir, and zanamivir), previous studies have not demonstrated conclusively to what extent these medications affect influenza viral shedding. This study will evaluate whether oseltamivir modifies the viral shedding during the treatment of uncomplicated influenza in an adult population and also assess methods to detect viral replication in the upper respiratory tract.
Subjects who presented with an influenza-like illness without any risk factors for severe disease were screened for the study. Those with a confirmatory test for influenza (rapid antigen or polymerase chain reaction [PCR]) were randomized in a 1:1 manner to receive a blinded study treatment consisting of either the oseltamivir or placebo for 5 days. Clinical, virologic, and laboratory assessments on Days 1, 3, 7, and 28 were used for both safety and efficacy analysis.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's enrollment of 716 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.
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History of an influenza-like illness defined as:
1) One or more respiratory symptom (cough, sore throat, or nasal symptoms)
Exclusion Criteria:
Presence of a medical condition(s) that had been associated with increased risk of complications from influenza
Drug: Oseltamivir
Drug: Placebo
Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap 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.
Time frame: At Day 3
Number of Participants by Virus Detection Status--Team Collected Samples
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
Time frame: At Day 0, 3 and 7
qPCR Viral Shedding -- Team Collected Samples
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.)
Time frame: At Day 0, 3 and 7
Number Of Participants Shedding Virus -- Team Collected Samples
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).
Time frame: At day 3 and 7.
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 was defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms were grade 0 (absent) or 1 (mild). A measurement was considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements were obtained per day) and then the daily assessment thereafter. Time was calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfied this criterion, then the duration was 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.
Time frame: From treatment initiation to Day 28
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.
Time frame: From treatment initiation to Day 28
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.
Time frame: From treatment initiation to Day 28
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.
Time frame: From treatment initiation to Day 28
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.
Time frame: From treatment initiation to Day 28
Time to Return of Physical Function to Pre-illness Level
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.
Time frame: From treatment initiation to Day 28
Number of Participants With Treatment Compliance Status
For each of the 5 days of treatment, participants were asked whether they took all study drug for that day. All participants were assumed to have taken at least some study drug even if they had zero days with all study drug reported as taken. Missing reports for some or all days were imputed as not having taken all study drug for the days concerned.
Time frame: From treatment initiation to Day 5
Percentage of Participants Who Required Hospitalization.
The percentage of participants hospitalized by 28 days was constructed by inverting an exact binomial test of the actual percentages (ignoring loss to follow-up).
Time frame: From treatment initiation to Day 28
Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications Requiring An Antibiotic Use, 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.
Time frame: From treatment initiation to Day 28
28-day Mortality
Number of deaths
Time frame: From treatment initiation to Day 28
Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples
For participants with a positive influenza test result at Day 0 from qualitative PCR testing on the team collected sample, the laboratory then performed qPCR testing of self-collected samples to quantify viral shedding.
Time frame: At Day 3
Number of Participants by Virus Detection Status --Self Collected Samples
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. Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
Time frame: At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3
qPCR Viral Shedding -- Self Collected Samples
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.). Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
Time frame: At Day 0, Day 0 evening, Day 1, Day 1 evening, Day 2, Day 2 evening and Day 3
Area Under The Curve (AUC) Of Viral Shedding For Self Collected Samples
This AUC was calculated using the trapezoidal rule and the units of measurement are (days\*log10 copies/mL) with the fact that it was the level of virus above the LLOQ being considered. The calculation of AUC was undertaken using measurements from Day 0 to Day 3 which were collected under all versions of the protocol (i.e. evening measurements on Days 0, 1 and 2 were not used as these were collected for only about 20% of subjects). Missing values during follow-up were ignored. This is equivalent to imputing a missing value using linear interpolation between the preceding and succeeding available values. For the five subjects with missing values following a last available measurement which was above the LLOQ, the remaining values were assumed to be the mean of preceding value and LLOQ in calculating the AUC.
Time frame: From Day 0 to Day 3
Participants with an influenza-like illness and diagnosed with influenza by rapid antigen or PCR were recruited at 42 sites from 3 countries: 3 from Argentina, 4 from Thailand and 35 from the U.S., between January 2012 to October 2017.
| Milestone | Oseltamivir | Placebo |
|---|---|---|
| Started | 278 | 280 |
| Completed | 273 | 274 |
| Not completed | 5 | 6 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Received non-randomized study drug | 0 | 1 |
| Withdrew: Never started treatment | 1 | 0 |
The central laboratory performed a qualitative PCR test on the NP sample from Day 0 team collected swap 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.
| Participants | Oseltamivir | Placebo |
|---|---|---|
| Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs at Day 3 -- Team Collected Samples | 99 | 131 |
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
| Participants | Oseltamivir | Placebo |
|---|---|---|
| Day 0 — >= LLOQ | 237 | 245 |
| Day 0 — >= LOD, < LLOQ | 6 | 5 |
| Day 0 — < LOD | 3 | 5 |
| Day 0 — Missing | 0 | 0 |
| Day 3 — >= LLOQ | 85 | 109 |
| Day 3 — >= LOD, < LLOQ | 24 | 36 |
| Day 3 — < LOD | 134 | 107 |
| Day 3 — Missing | 3 | 3 |
| Day 7 — >= LLOQ | 16 | 21 |
| Day 7 — >= LOD, < LLOQ | 11 | 5 |
| Day 7 — < LOD | 214 | 224 |
| Day 7 — Missing | 5 | 5 |
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.)
| log10 copies/mL | Oseltamivir | Placebo |
|---|---|---|
| Day 0 | 6.85 (5.8 to 7.6) | 6.9 (5.9 to 7.6) |
| Day 3 | 3.4 (3.2 to 4.5) | 3.9 (3.2 to 4.9) |
| Day 7 | 3.2 (3.2 to 3.4) | 3.2 (3.2 to 3.4) |
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).
| Participants | Oseltamivir | Placebo |
|---|---|---|
| Undetectable at both Day 3 and 7 | 126 | 100 |
| Detectable at Day 3 and undetectable at Day 7 | 87 | 124 |
| Detectable at Day 7 | 27 | 26 |
| Missing result at Day 3 and/or Day 7 | 6 | 5 |
The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms was defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms were grade 0 (absent) or 1 (mild). A measurement was considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements were obtained per day) and then the daily assessment thereafter. Time was calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfied this criterion, then the duration was 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.
| days | Oseltamivir | Placebo |
|---|---|---|
| Time to Alleviation of Influenza Clinical Symptoms | 4 (3.5 to 4.5) | 4 (3.5 to 4.5) |
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.
| days | Oseltamivir | Placebo |
|---|---|---|
| Time to Absence of Fever | 1 (0.5 to 1.0) | 1 (0.5 to 1.0) |
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.
| days | Oseltamivir | Placebo |
|---|---|---|
| Time to Resolution of All Symptoms AND Fever | 4.0 (3.5 to 4.5) | 4.0 (3.5 to 4.5) |
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.
| days | Oseltamivir | Placebo |
|---|---|---|
| Time to Feeling as Good as Before the Onset of the Influenza Illness | 6.0 (5.0 to 6.5) | 6.0 (5.5 to 6.5) |
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.
| days | Oseltamivir | Placebo |
|---|---|---|
| Time to Return to Pre-influenza Function | 3.5 (3.5 to 4.5) | 5.0 (4.0 to 5.0) |
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.
| days | Oseltamivir | Placebo |
|---|---|---|
| Time to Return of Physical Function to Pre-illness Level | 7.0 (6.0 to 8.0) | 7.0 (6.0 to 7.0) |
For each of the 5 days of treatment, participants were asked whether they took all study drug for that day. All participants were assumed to have taken at least some study drug even if they had zero days with all study drug reported as taken. Missing reports for some or all days were imputed as not having taken all study drug for the days concerned.
| Participants | Oseltamivir | Placebo |
|---|---|---|
| 0 day with all study drug reported as taken | 1 | 2 |
| 1 day with all study drug reported as taken | 2 | 2 |
| 3 days with all study drug reported as taken | 2 | 1 |
| 4 days with all study drug reported as taken | 2 | 1 |
| 5 days with all study drug reported as taken | 270 | 273 |
The percentage of participants hospitalized by 28 days was constructed by inverting an exact binomial test of the actual percentages (ignoring loss to follow-up).
| percentage of participants | Oseltamivir | Placebo |
|---|---|---|
| Percentage of Participants Who Required Hospitalization. | 1.4 (0.4 to 3.7) | 0.7 (0.1 to 2.6) |
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.
| percentage of participants | Oseltamivir | Placebo |
|---|---|---|
| Sinusitis | 3.2 | 1.8 |
| Otitis Media | 0.4 | 0.4 |
| Bronchitis Bronchiolitis | 2.5 | 2.2 |
| Pneumonia | 0.4 | 0.4 |
| Antibiotic use | 2.5 | 3.6 |
| If have at least one Complication | 7.2 | 6.8 |
Number of deaths
| Participants | Oseltamivir | Placebo |
|---|---|---|
| 28-day Mortality | 0 | 0 |
For participants with a positive influenza test result at Day 0 from qualitative PCR testing on the team collected sample, the laboratory then performed qPCR testing of self-collected samples to quantify viral shedding.
| Participants | Oseltamivir | Placebo |
|---|---|---|
| Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs --Self Collected Samples | 56 | 89 |
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. Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
| Participants | Oseltamivir | Placebo |
|---|---|---|
| Day 0 — >= LLOQ | 217 | 225 |
| Day 0 — >= LOD, < LLOQ | 11 | 6 |
| Day 0 — < LOD | 17 | 23 |
| Day 0 — Missing | 1 | 1 |
| Day 0 evening — >= LLOQ | 37 | 48 |
| Day 0 evening — >= LOD, < LLOQ | 4 | 1 |
| Day 0 evening — < LOD | 8 | 5 |
| Day 0 evening — Missing | 197 | 201 |
| Day 1 — >= LLOQ | 138 | 147 |
| Day 1 — >= LOD, < LLOQ | 30 | 27 |
| Day 1 — < LOD | 75 | 76 |
| Day 1 — Missing | 3 | 5 |
| Day 1 evening — >= LLOQ | 23 | 29 |
| Day 1 evening — >= LOD, < LLOQ | 4 | 9 |
| Day 1 evening — < LOD | 24 | 13 |
| Day 1 evening — Missing | 195 | 204 |
| Day 2 — >= LLOQ | 70 | 92 |
| Day 2 — >= LOD, < LLOQ | 26 | 31 |
| Day 2 — < LOD | 146 | 129 |
| Day 2 — Missing | 4 | 3 |
| Day 2 evening — >= LLOQ | 11 | 12 |
| Day 2 evening — >= LOD, < LLOQ | 6 | 4 |
| Day 2 evening — < LOD | 32 | 41 |
| Day 2 evening — Missing | 197 | 198 |
| Day 3 — >= LLOQ | 39 | 65 |
| Day 3 — >= LOD, < LLOQ | 25 | 35 |
| Day 3 — < LOD | 178 | 149 |
| Day 3 — Missing | 4 | 6 |
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.). Evening samples on Day 0, 1 and 2 were only required under protocol versions 1.0-4.0 and so were only collected for about 20% of participants.
| log10 copies/mL | Oseltamivir | Placebo |
|---|---|---|
| Day 0 | 6.1 (4.9 to 6.9) | 6.2 (5.4 to 6.9) |
| Day 0 evening | 5.5 (4.3 to 6.2) | 6.0 (5.0 to 6.6) |
| Day 1 | 4.2 (3.4 to 5.5) | 4.5 (3.4 to 5.9) |
| Day 1 evening | 3.9 (3.2 to 7.2) | 4.0 (3.4 to 5.6) |
| Day 2 | 3.4 (3.2 to 4.3) | 3.4 (3.2 to 4.8) |
| Day 2 evening | 3.2 (3.2 to 3.9) | 3.2 (3.2 to 3.9) |
| Day 3 | 3.2 (3.2 to 3.9) | 3.4 (3.2 to 4.0) |
This AUC was calculated using the trapezoidal rule and the units of measurement are (days\*log10 copies/mL) with the fact that it was the level of virus above the LLOQ being considered. The calculation of AUC was undertaken using measurements from Day 0 to Day 3 which were collected under all versions of the protocol (i.e. evening measurements on Days 0, 1 and 2 were not used as these were collected for only about 20% of subjects). Missing values during follow-up were ignored. This is equivalent to imputing a missing value using linear interpolation between the preceding and succeeding available values. For the five subjects with missing values following a last available measurement which was above the LLOQ, the remaining values were assumed to be the mean of preceding value and LLOQ in calculating the AUC.
| days*log10 copies/mL | Oseltamivir | Placebo |
|---|---|---|
| Area Under The Curve (AUC) Of Viral Shedding For Self Collected Samples | 12.5 (11.35 to 14.55) | 13.18 (11.55 to 15.75) |
Collected over Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oseltamivir | 0/277 (0%) | 5/277 (1.8%) | 134/277 (48.4%) |
| Placebo | 0/279 (0%) | 2/279 (0.7%) | 153/279 (54.8%) |
| Event | Oseltamivir | Placebo |
|---|---|---|
| InfluenzaInfections and infestations | 2/277 | 1/279 |
| SinusitisInfections and infestations | 1/277 | 0/279 |
| VomitingGastrointestinal disorders | 1/277 | 0/279 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/277 | 0/279 |
| Chest painGeneral disorders | 0/277 | 1/279 |
| Event | Oseltamivir | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 65/277 | 61/279 |
| DiarrhoeaGastrointestinal disorders | 41/277 | 47/279 |
| VomitingGastrointestinal disorders | 35/277 | 36/279 |
| CoughRespiratory, thoracic and mediastinal disorders | 28/277 | 32/279 |
| PyrexiaGeneral disorders | 31/277 | 27/279 |
| HeadacheNervous system disorders | 28/277 | 24/279 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 26/277 | 23/279 |
| FatigueGeneral disorders | 24/277 | 26/279 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 24/277 | 25/279 |
| DizzinessNervous system disorders | 22/277 | 15/279 |
The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.
| Age, Categorical(Participants) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| <=18 years | 6 | 6 | 12 |
| Between 18 and 65 years | 271 | 273 | 544 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| Median | 37 (27 to 49) | 35 (27 to 46) | 36 (27 to 47) |
| Sex: Female, Male(Participants) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| Female | 183 | 164 | 347 |
| Male | 94 | 115 | 209 |
| Ethnicity (NIH/OMB)(Participants) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 13 | 24 |
| Not Hispanic or Latino | 265 | 266 | 531 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| Race — Asian | 193 | 192 | 385 |
| Race — White | 74 | 76 | 150 |
| Race — Black or African American | 7 | 11 | 18 |
| Race — Race not available to clinic | 1 | 0 | 1 |
| Race — Subject does not know | 1 | 0 | 1 |
| Race — Subject does not want to report | 1 | 0 | 1 |
| Region of Enrollment(participants) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| Argentina | 4 | 8 | 12 |
| United States | 91 | 87 | 178 |
| Thailand | 182 | 184 | 366 |
| Confirmed influenza infection status by central testing(Participants) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| Count of participants | 246 | 255 | 501 |
| Influenza type/subtype by central testing(Participants) | Oseltamivir | Placebo | Total |
|---|---|---|---|
| Influenza A/H3N2 | 122 | 129 | 251 |
| Influenza A/H1N1 | 39 | 54 | 93 |
| Influenza B | 85 | 71 | 156 |
| Negative | 30 | 22 | 52 |
| Co-infection | 0 | 1 | 1 |
| Missing | 1 | 2 | 3 |
13 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
The record gives a start of Apr 2011, a primary completion of Nov 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2019, 1 year 2 months after primary completion.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oseltamivir
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