CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 881 enrolled
Drug / intervention
Amantadine, Ribavirin, Oseltamivir +1 moredrug
Likely dose
Amantadine, Ribavirin, Oseltamivir 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01227967
NCT01227967Phase 2Completed

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 25, 2010·Updated Feb 4, 2019

In Brief

A Phase 2 clinical trial evaluating Amantadine, Ribavirin, Oseltamivir and Oseltamivir for Influenza. Completed, enrolled 881 participants across 91 sites in 5 countries.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesArgentina, Australia, Mexico, Thailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartSep 1, 2010
Primary CompletionMay 2, 2016
Study CompletionMar 30, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 15.7 years ago

Interventions

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.