What are the COVID-19 studies?
The COVID-19 studies are clinical research studies that have been designed to learn more about potential new vaccines or monoclonal antibodies for the prevention of COVID-19. Vaccinations for other diseases have saved millions of lives in the past and we are looking for ways to save lives in the future.
COVID-19 is an infectious disease caused by the novel coronavirus, SARS-CoV-2. The COVID-19 pandemic now affects many countries around the world.
Currently, no vaccines or monoclonal antibodies have been approved or licensed to prevent SARS-CoV-2 from infecting people. These trials, which are testing potential new vaccines and monoclonal antibodies, are looking for volunteers who are interested in helping to find new ways to prevent COVID-19.
The studies are looking at how safe the potential new vaccines or antibodies are and how well they work.
The overall goal for these types of studies is to find a medication that can prevent SARS-CoV-2 from infecting people and causing COVID-19.
What to expect
If you qualify and decide you’d like to take part in one of the studies, the length of the study and the assessments will vary. You will be looked after by a dedicated study team who will be able to answer your questions throughout the study. You will have some appointments with the study doctor or clinical research staff for tests and assessments. Appointments might be at your home, at a study center or mobile unit, via telephone, or online.
Several tests and assessments will take place to monitor your health. These will include:
- Questionnaires about your general health and how you are feeling
- Physical examinations
- Measurement of vital signs (such as blood pressure, heart rate, breathing rate, oxygen saturation, and temperature)
- A COVID-19 test for some participants
The study medication
If you take part in a COVID-19 study, you will be randomly assigned to receive either the investigational medication (vaccine or monoclonal antibodies) or a placebo.
A placebo looks like the investigational medication but contains no active ingredients. The investigational medication or placebo will be administered as injection(s) (a shot) into a muscle in your arm or buttock.
Vaccines are designed to prevent a disease by working with the body’s immune system to build natural defenses to the invading virus or germ. Vaccines can prevent people from getting a disease.
Antibodies are protein molecules that the body produces to help fight infections. Man-made antibodies created by scientists in a laboratory are sometimes used to fight or prevent diseases.
Who can take part?
You may be able to take part in the COVID-19 studies if you:
You will need to meet all other study criteria to take part in the COVID-19 studies.
The decision to take part in a clinical research study is personal, and each person has their own reason for participating or not. Some volunteers take part in research to help people, while others who decide to take part want to advance medical knowledge.
It is important to note that there is no obligation to participate, and even if you decide to participate, you can change your mind at any point.