Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01227967 · ClinicalTrials.gov registry record · Phase 2
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 of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 881
- Enrollment target
- 20
- Study locations
NCT01227967: Completed Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01227967 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 881 participants, below the 36,798-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227967, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 881 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Oseltamivir
- DRUG Amantadine, Ribavirin, Oseltamivir
Study Locations (20)
California
- WCCT Global LLC - Costa Mesa
- Advanced Rx Clinical Research - Garden Grove
- Torrance Clinical Research Institute, Inc. - Lomita
- University of Southern California - Los Angeles
- University of California at San Diego - San Diego
- Westlake Medical Research (CA) - Thousand Oaks
- Los Angeles BioMedical Research Institute - Torrance
- Empire Clinical Research - Upland
Florida
- University of Florida - Gainesville
- Best Quality Research Inc. - Hialeah
- San Marcus Research Clinic, Inc. - Miami
- Medical Consulting Center - Miami
- Suncoast Research Group, LLC - Miami
- University of Miami - Miami
Arizona
- East Valley Family Physicians - Chandler
- Thomas Lenzmeier Family Practice - Glendale
- Central Phoenix Medical Center - Phoenix
Colorado
- University of Colorado - Aurora
- Centennial - IMMUNOe International Research - Centennial
Alabama
- Simon Williamson Clinic - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 881 participants |
| Start Date | 2010-09 |
| Est. Completion | 2017-03-30 |
| Phase | Phase 2 |
What the finished NCT01227967 record still lists
NCT01227967 is an interventional study that assigns participants to a tested intervention. The registered 881 participants enrollment target is mid-sized for trials with a published cap, below the 36,798-participant average among 156 other Influenza trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Oseltamivir is the first listed.
NCT01227967 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01227967 about?
NCT01227967 is a clinical study titled "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 d...
What is the current status of trial NCT01227967?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 881 participants. The study started on 2010-09. Estimated completion is 2017-03-30.
What conditions does trial NCT01227967 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01227967?
The interventions under investigation include: Oseltamivir (DRUG), Amantadine, Ribavirin, Oseltamivir (DRUG).
Who is sponsoring clinical trial NCT01227967?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01227967 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01227967's enrollment target sits among peer trials
881 39th of 156 higher than 118 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
RECRUITING · Phase 2
-
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
RECRUITING · Phase 2
-
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
RECRUITING · Phase 2
-
Systems Investigation of Vaccine Responses in Aging and Frailty
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07196748 · 882 participants · Phase 3
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
- NCT05174286 · 880 participants · NA
Community Health Workers United to Reduce Colorectal Cancer and Cardiovascular Disease Among People at Higher Risk
- NCT05454280 · 880 participants · Phase 3
Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)
- NCT05525663 · 880 participants · NA
Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia