Every year, thousands of people around the world take part in clinical research studies.
What is a clinical research study?
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 and ensuring their safety
- Making sure they are not exposed to unnecessary risks
What happens during the study?
If you qualify and decide to enroll in the CAPSTONE-2 study, you will remain in the study for approximately 22 days in total. You will be randomly (by chance) assigned a study group. You will not know which group you have been assigned to, and neither will the study team.
Once you have finished taking the study drug, you will enter the follow-up period and continue to be monitored until day 22 of the study. During this time, we will continue to check your general health.
CAPSTONE-2 will find out whether an investigational drug can speed up the recovery of people with flu 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)
- To do this we need to recruit about 2157 people worldwide, who:
- Have had flu symptoms (such as fever, aches, pains, cough, sore throat) for less than 48 hours
- Are 12 years and older
What is the criteria?
Must meet at least one of the following criteria:
- Asthma or chronic lung disease (such as chronic obstructive pulmonary disease [COPD] or cystic fibrosis)
- Endocrine disorders (including diabetes mellitus)
- Residents of long-term care facilities (eg, nursing homes)
- Compromised immune system (including patients receiving corticosteroids not exceeding 20 mg of prednisolone or equivalent, and patients being treated for human immunodeficiency virus (HIV) infection with a CD4 count > 350 cells/mm3 within the last 6 months)
- Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure disorders], stroke, muscular dystrophy, or spinal cord injury)
- Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
- Adults aged ≥65 years
- American Indians and Alaskan Natives
- Blood disorders (such as sickle cell disease)
- Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
- Morbid obesity (body mass index [BMI] ≥40)
- Women who are within 2 weeks postpartum and are not breastfeeding
How will health be monitored?
- Physical examinations
- Vital signs checks (pulse and blood pressure)
- ECGs (test of electrical activity of the heart)
- Blood tests
- Nasopharyngeal (far back of nose) swabs
- Pharyngeal (throat) swabs
- You will also be asked to complete a daily questionnaires about your health
Why do some participants receive a placebo?
Placebos are often used in clinical research studies to help researchers determine how effective the investigational drug is. Without a placebo, it’s very difficult to determine whether any changes during the study are due to the investigational drug or some other factor. Placebo-controlled studies are usually ‘double blind’. This means that neither the study doctor not the participant know whether they are receiving the investigational drug or a placebo.
Do participants have to pay anything?
All study-related drugs and health checks will be provided at no additional cost. You do not need health insurance, and compensation for time or travel may be provided.
Is taking part mandatory?
Taking part in a clinical research study is entirely voluntary. You can leave the study at any time (even if you’ve started taking the study drug).
What is Informed Consent?
Before participants receive any study drug, they will need to read and sign an informed consent form to show that they understand what the study involves and agree to take part. Participants under 18 years old may be given a simpler version of this form to read and sign too. This is called an informed assent form.
Call 737-247-7240, or contact us online.