capstone Flu study

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About the
Capstone study

We all get colds now and again, but ‘the flu’ is different. It is a virus that can keep you in bed for days and leave you feeling tired and run down for weeks. So finding better ways to treat the flu is vital.

CAPSTONE-2 is a clinical research study trying to do just that. The study will find out whether an investigational drug can speed up the recovery of people who have had flu symptoms (such as fever, aches, pains, cough, sore throat) within 48 hours, when compared with:

  • A placebo (a look-alike that contains no drug)
  • A drug that has already been approved to treat flu called Tamiflu® (also known as oseltamivir)
CAPSTONE-2
For people with flu who are at risk of developing complications

About 2,157 people aged 12 and older are expected to take part worldwide

If you qualify and decide to enroll in the CAPSTONE-2 study, you will remain in the study for approximately 22 days.

On the first day, we will assess your suitability for the study, assign you to a study group and give you your first dose of drug.

You will continue to take doses of study drug over days 2–5, unless you take the first dose of study drug after 6pm on the first day of the study. Then, your final dose of study drug will be on the morning of day 6.

For the rest of the time (days 6–22), we will continue to monitor your health.

Those taking part in CAPSTONE-2 will be randomly (by chance) placed into one of three groups.

 

capstone-2 Group 1 Group 2 Group 3
Investigational medication 2 or 4 tablets on day 1*
Placebo version of investigational medication 2 or 4 tablets on day 1* 2 or 4 tablets on day 1*
Tamiflu® 1 capsule twice daily on days 1–5**
Placebo version of Tamiflu® 1 capsule twice daily on days 1–5** 1 capsule twice daily on days 1–5**

*Whether participants receive 2 or 4 tablets will be dependent on their weight at screening.

**If participants take their first dose of study drug after 5pm on the first day of the study, the last dose of study drug will be taken on the morning of day 6.

Taking part in the study will mean visiting a clinic between seven and nine times.

During your visits to the clinic, study doctors will assess your flu symptoms and general health using:

  • Physical Examinations
  • Vital signs checks
    (pulse and blood pressure)
  • ECGs
    (test of electrical activity of the heart)
  • Blood tests
  • Questionnaires
  • Nasopharyngeal
    (far back of nose) swabs
    (this method is mandatory)
  • Pharyngeal (throat) swabs
    (if nasopharyngeal swabs cannot be collected)
  • You will also be asked to complete daily
    questionnaires about your health.

We will continue to monitor your health.

From day 6 to day 22 (after you have finished taking the study drugs), we will continue to follow you to monitor your health and check for any side effects.

Health checks, along with any study-related drugs, will be provided at no additional cost. You do not need health insurance, and compensation for time or travel may be provided.

What is a clinical
research study?

Every year, thousands of people around the world take part in clinical research studies.

Doctors and nurses carry out these carefully designed scientific tests to help us answer questions about investigational drugs such as:

  • How it acts in the body
  • How it affects certain diseases or conditions
  • Whether or not it is safe for wider use

Independent review boards and ethics committees look after the best interests of the participants by:

  • Protecting their rights
  • Protecting their safety or ensuring their safety
  • Making sure they are not exposed to unnecessary risks