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COMPLETED 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

NCT01227967 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 881 participants
Start Date 2010-09
Est. Completion 2017-03-30
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01227967

The ClinicalTrials.gov registry entry for NCT01227967 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 881 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01227967 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01227967?

The interventions under investigation include: Oseltamivir (DRUG), Amantadine, Ribavirin, Oseltamivir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01227967?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial