Flu Study

CAN WE TAKE ON THE FLU, AS SOON AS THE FLU TAKES ON YOU?

Can I take part?

Those taking part must have had:

Fever of 38 °C (100.4 °F) or above
Nasal congestion, cough, or sore throat
Headache, muscle or joint aches, or fatigue

(call us at 562-404-9774 if these symptoms are present for less than 48 hours or for more information.)

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

About the CAPSTONE program

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-1 and -2 are clinical research studies trying to do just that. The studies 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)

Duration

If you qualify and decide to enroll in one of the CAPSTONE studies, 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.

Treatment

Those taking part in CAPSTONE-1 will be randomly (by chance) placed into one of three groups.

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

CAPSTONE-1

	Group 1	Group 2	Group 3
	20-64 years old
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**

CAPSTONE-2

	Group 1	Group 2	Group 3
	20 years old and over
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 6pm on the first day of the study, the last dose of study drug will be taken on the morning of day 6

Visits

Taking part in both studies 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 preferred)
Pharyngeal (throat) swabs (if nasopharyngeal swabs cannot be collected)

You will also be asked to complete daily questionnaires about your health.

Follow-up

We will continue to monitor your health.

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

No cost to you

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 is provided.

Am I suitable for either of the CAPSTONE studies?

To take part in a clinical research study, you must meet a set of requirements. CAPSTONE-1 and CAPSTONE-2 have slightly different requirements.

Because you need to enroll in the study within 48 hours of becoming ill, it is important to get in touch as soon as soon as possible after symptoms appear.

To see if you could be suitable for either study, please answer the following questions (this information will be kept confidential). If you’d prefer to answer these questions on the phone, please call 562-404-9774.

	CAPSTONE-1		CAPSTONE-2
	Eligible	Not eligible	Eligible	Not eligible
Do you have symptoms of flu (fever, headache, chills, fatigue, cough, sore throat)?	Yes	No	Yes	No
Are you aged 20 or older?	Yes	No	Yes	No
How long have you been suffering from flu symptoms?	Less than 48 hours	48 or more hours	Less than 48 hours	48 or more hours
Do you have a history of asthma or chronic lung disease?	No (answering no to all* of these questions makes them eligible for the study)*	Yes (answering yes to one or more* of these questions makes them ineligible)*	Yes (answering yes to any one* (or more) of these questions makes them eligible)*	No (answering no to all* of these questions makes them ineligible)*
Do you have a history of endocrine disorders (e.g., diabetes)?
Are you a resident of a long-term care facility?
Do you have a compromised immune system? (e.g., from HIV infection?)
Do you have a history of neurological or neurodevelopmental disorder (e.g., cerebral palsy, epilepsy, stroke, muscular dystrophy or spinal cord injury)?
Do you have a history of heart disease (e.g., congenital heart disease, congestive heart failure or coronary artery disease)?
Are you aged 65 or older?
Are you an American Indian or Alaskan Native?
Do you have a blood disorder (e.g., anemia or sickle cell disease)?
Do you have a history of metabolic disorder (e.g., Hunter syndrome, Fabry disease or Tay-Sachs disease)?
Are you classed as morbidly obese (body mass index (BMI of 40 or more)?
Did you give birth within the past 2 weeks, and are not breastfeeding?

Once again – thank you!

The study team will be in touch with you shortly.