Influenza affects anywhere from
5% to 20% of North Americans each year,
and results in approximately
200,000 hospitalizations. Flu
symptoms can range from
mild to severe and can persist
for as long as two weeks.



About The Influence Study

A Global Flu study
The Influence Study is a clinical research study evaluating the safety and effectiveness of an investigational
oral medication for the treatment of uncomplicated Influenza. If you are suffering from Flu symptoms,
we hope you will consider participating in The Influence Study.

Who can Participate?


  • - Have a fever greater than: 100.4 F

  • - AND be experiencing at least one of the following: cough, sore throat,
    or nasal obstruction considered by patient to be moderate to severe

  • - AND be experiencing one of the following constitutional symptoms: fatigue,
    headache, myalgia, feverishness considered by patient to be moderate to severe

  • - Have experienced flu symptoms for less than 48 hours
    prior to enrolling in trial

  • - Have NOT received a flu vaccine ("flu shot") after August 1,2013

What Happens During The Study?

Before beginning The Influence Study you will be screened for eligibility. If you are determined to be eligible, and you agree to participate, you will be randomly placed into one of the dosing groups, with one group receiving placebo version versus study drug. You and your doctor will not know your dosing group assignment, however in the event of an emergency; this information will be provided to your doctor. After you join the study, you will be scheduled for four (4) office visits over the course of one (1) month. Study sites will contact subjects daily for the first five (5) days of the study. During your visit, you will be asked to complete a diary daily, and you will receive the study drug, as well as have doctors monitor your health and progress through various related tests and assessments. Subjects will complete four to eight (4-8) nasopharyngeal swabs and three to five (3-5) blood draws during study.

What are the potential risks and benefits associated with participating in this study?

Potential Benefits Include:
  • - Access to an investigational drug that isn't available yet
  • - Access to and care at no cost from doctors and researchers for study related procedures
  • - Contribute to research that may improve the lives of others

  • Potential Risks Include:
  • - Not being able to choose if you will receive investigational drug or placebo
  • - The investigational drug or placebo may not work for you
  • - Side effects may occur

What is Influenza?

Influenza, also called 'Flu', is a highly contagious respiratory illness caused by viruses that attack the nose, throat, and lungs. Flu symptoms include fever, chills, cough, sore through, runny or stuffy nose, aches, fatigues, and even vomiting or diarrhea. Symptoms can range from mild to severe.

Where is The Influence Study being conducted?

The Influence Study is being conducted at research sites throughout the US and Canada. Please enter your information into the Register for this study form, and a local study site will contact you shortly.

FAQ on Clinical Trials

Please refer below to frequently asked questions about clinical research trials.

What is a clinical trial?
A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
What happens during a clinical trial?
The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What happens during a clinical trial?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The clinical trial will be performed in accordance with the guidelines set by the World Medical Assembly (Declaration of Helsinki, last amendment in Seoul, October 2008). Prior written approval of the study protocol and of the informed consent form will be obtained from the appropriate local Medical Ethics Review Board. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Source: http://www.ciscrp.org/patient/faqs.html

Contact

To be contacted by a research team member in your area,
please fill out the following information.

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