Trial · NCT01231620
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
NCT01231620, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza. Trials, record NCT01231620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01231620
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
- NCT number
- NCT01231620
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 626 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza, Human
- Interventions
- Zanamivir, Placebo to match zanamivir, Oseltamivir, Placebo to match oseltamivir
- First posted
- 2010-11-01
- Last updated
- 2018-10-15
- Results first posted
- 2017-11-20
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Clinical Response (TTCR) in Participants With Confirmed Influenza | Up to 42 days | Clinical response is defined as the resolution of at least 4 of the 5 vital signs (temperature, oxygen saturation, respiratory status, heart rate, systolic blood pressure) within the respective resolution criteria, maintained for at least 24 hours, or hospital discharge, whichever occurred first. This analysis was performed for Influenza positive population, for those with symptom onset less than or equal to (\<=) 4 days, and for those on mechanical (mech) ventilation or in intensive care unit (ICU). 99 days is censored time for the participants who did not achieve TTCR. |
| Secondary | Percentage of Participants With Respiratory Improvement | Up to 42 days | Respiratory Status (RS) is a component of TTCR. Response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), a need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate of =\<24 breaths/minute (without supplemental oxygen). Data are presented as the percentage of participants achieving respiratory improvement. |
| Secondary | Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit | On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days) | The number of participants who died on or before Day 14, Day 28, and the End of Study Visit were summarized. |
| Secondary | Change From Baseline in the Katz Activities of Daily Living (ADL) Score and Each ADL Activity Score | Baseline (Day 1) and up to 42 days | The Katz ADL scores were collected for bathing, dressing, toileting, transferring, continence, and feeding activities and were assessed once daily during the treatment period/hospitalization and once at each post-treatment Clinic Visit. For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline is defined as the difference at each time point (Day 5/6, and Day 10/11, and last day S/R if treatment was extended beyond 5 days) and the end of the study (post-treatment \[PT\] +28 Days) compared to Baseline. |
| Secondary | Median Time to Return to Pre-morbid Functional Status as Measured by the Katz ADL Score and Each ADL Activity Score | Up to 42 days | Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. Median time to return to pre-morbid functional status was assessed via the Katz ADL score (bathing, dressing, toileting, transferring, continence, and feeding activities). For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent. |
| Secondary | Number of Participants Who Returned to Their Pre-morbid Functional Status as Assessed Per the Katz ADL Score and Each ADL Activity Score at the End of the Study | Up to 42 days | Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. The number of participants who returned to their pre-morbid functional status at the end of the study assessed per the Katz ADL score (bathing, dressing, toileting, transferring, continence and feeding activities) is summarized. |
| Secondary | Median Time to Return to the Pre-morbid Level of Activity as Measured by the 3-point Scale | Up to 42 days | Median time to return to pre-morbid level of activity was assessed once daily during treatment/hospitalization and once at each post-treatment assessment and was measured using the 3- point scale (bed rest, limited ambulation, or unrestricted). |
| Secondary | Number of Participants With the Indicated Clinical Symptoms of Influenza | Up to 42 days | Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient hospitalization and once at each post-treatment assessment. |
| Secondary | Median Time of Duration of Clinical Symptoms of Influenza | Up to 42 days | Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient/hospitalization and once at each post-treatment assessment. |
| Secondary | Number of Participants With Complications of Influenza and Associated Antibiotic Use | Up to 42 days | The number of participants with complications of influenza and associated antibiotic use were summarized |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Clinical Response (TTCR) in Participants With Confirmed Influenza | Up to 42 days | ITT-E population comprised of all randomized participants who received at least one dose of investigational product. The Influenza positive population (IPP) is comprised of all participants in the ITT-E population with proven influenza infection. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Respiratory Improvement | Up to 42 days | IPP Population | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit | On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days) | IPP Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Katz Activities of Daily Living (ADL) Score and Each ADL Activity Score | Baseline (Day 1) and up to 42 days | IPP population. Only those participants available at the specified time points were analyzed. | Scores on the scale | MEAN |
| SECONDARY | Median Time to Return to Pre-morbid Functional Status as Measured by the Katz ADL Score and Each ADL Activity Score | Up to 42 days | IPP population. Only those participants available at the specified time points were analyzed. | Days | MEDIAN |
| SECONDARY | Number of Participants Who Returned to Their Pre-morbid Functional Status as Assessed Per the Katz ADL Score and Each ADL Activity Score at the End of the Study | Up to 42 days | IPP Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to Return to the Pre-morbid Level of Activity as Measured by the 3-point Scale | Up to 42 days | IPP Population. Participants succeeded in pre-morbid functional status were analyzed. | Days | MEDIAN |
| SECONDARY | Number of Participants With the Indicated Clinical Symptoms of Influenza | Up to 42 days | IPP Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time of Duration of Clinical Symptoms of Influenza | Up to 42 days | IPP Population. Only those participants available at the specified time points were analyzed. | Days | MEDIAN |
| SECONDARY | Number of Participants With Complications of Influenza and Associated Antibiotic Use | Up to 42 days | IPP Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group951
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Clinical Response (TTCR) in Participants With Confirmed Influenza | IV Zanamivir 300 mg | 5.87 | Full Range 0.12 to 99.90 | Days | |
| Time to Clinical Response (TTCR) in Participants With Confirmed Influenza | IV Zanamivir 600 mg | 5.14 | Full Range 0.23 to 99.90 | Days | |
| Time to Clinical Response (TTCR) in Participants With Confirmed Influenza | Oral Oseltamivir 75 mg | 5.63 | Full Range 0.03 to 99.90 | Days | |
| Percentage of Participants With Respiratory Improvement | IV Zanamivir 300 mg | 77 | Percentage of participants | ||
| Percentage of Participants With Respiratory Improvement | IV Zanamivir 600 mg | 78 | Percentage of participants | ||
| Percentage of Participants With Respiratory Improvement | Oral Oseltamivir 75 mg | 74 | Percentage of participants | ||
| Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit | IV Zanamivir 300 mg | Died on or before Study Day 14: all cause | 5 | Participants | |
| Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit | IV Zanamivir 600 mg | Died on or before Study Day 14: all cause | 8 | Participants | |
| Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit | Oral Oseltamivir 75 mg | Died on or before Study Day 14: all cause | 5 | Participants | |
| Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit | IV Zanamivir 300 mg | Died on or before Study Day 28: all cause | 8 | Participants |
1 to 10 of 951Source ClinicalTrials.gov
See all 951 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV Zanamivir 300 mg | 201 | |
| Overall Study | STARTED | IV Zanamivir 600 mg | 209 | |
| Overall Study | STARTED | Oral Oseltamivir 75 mg | 205 | |
| Overall Study | COMPLETED | IV Zanamivir 300 mg | 175 | |
| Overall Study | COMPLETED | IV Zanamivir 600 mg | 178 | |
| Overall Study | COMPLETED | Oral Oseltamivir 75 mg | 166 | |
| Overall Study | NOT COMPLETED | IV Zanamivir 300 mg | 26 | |
| Overall Study | NOT COMPLETED | IV Zanamivir 600 mg | 31 | |
| Overall Study | NOT COMPLETED | Oral Oseltamivir 75 mg | 39 |
Source ClinicalTrials.gov
Adverse events303
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Intravenous (IV) Zanamivir 300mg Twice Daily | 10 | 201 | |
| other | Diarrhoea | Gastrointestinal disorders | Intravenous (IV) Zanamivir 600mg Twice Daily | 15 | 209 | |
| other | Diarrhoea | Gastrointestinal disorders | Oral Oseltamivir 75mg Twice Daily | 14 | 205 | |
| other | Constipation | Gastrointestinal disorders | Intravenous (IV) Zanamivir 300mg Twice Daily | 7 | 201 | |
| other | Constipation | Gastrointestinal disorders | Intravenous (IV) Zanamivir 600mg Twice Daily | 13 | 209 | |
| other | Constipation | Gastrointestinal disorders | Oral Oseltamivir 75mg Twice Daily | 10 | 205 | |
| serious | Deep vein thrombosis | Vascular disorders | Intravenous (IV) Zanamivir 300mg Twice Daily | 1 | 201 | |
| serious | Deep vein thrombosis | Vascular disorders | Intravenous (IV) Zanamivir 600mg Twice Daily | 0 | 209 | |
| serious | Deep vein thrombosis | Vascular disorders | Oral Oseltamivir 75mg Twice Daily | 0 | 205 | |
| serious | Distributive shock | Vascular disorders | Intravenous (IV) Zanamivir 300mg Twice Daily | 0 | 201 |
1 to 10 of 303Source ClinicalTrials.gov
See all 303 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravenous (IV) Zanamivir 300mg Twice Daily | 15 | 201 |
| Total, all-cause mortality | Intravenous (IV) Zanamivir 600mg Twice Daily | 15 | 209 |
| Total, all-cause mortality | Oral Oseltamivir 75mg Twice Daily | 11 | 205 |
| Total, other adverse events | Intravenous (IV) Zanamivir 300mg Twice Daily | 17 | 201 |
| Total, other adverse events | Intravenous (IV) Zanamivir 600mg Twice Daily | 26 | 209 |
| Total, other adverse events | Oral Oseltamivir 75mg Twice Daily | 24 | 205 |
| Total, serious adverse events | Intravenous (IV) Zanamivir 300mg Twice Daily | 38 | 201 |
| Total, serious adverse events | Intravenous (IV) Zanamivir 600mg Twice Daily | 33 | 209 |
| Total, serious adverse events | Oral Oseltamivir 75mg Twice Daily | 38 | 205 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01231620
GET https://conductscience.org/api/trials/v1/NCT01231620/registered?page=2