What is the PROVENT Study?

The PROVENT Study will research a combination of two investigational monoclonal antibodies for the prevention of COVID-19, the disease caused by the new coronavirus (SARS-CoV-2). The study is looking at how well the investigational antibodies work and how safe they are.

Research has shown that certain diseases and medications may impact people differently based on their age, gender, and genetic background, including race and ethnicity. For example, COVID-19 has disproportionally impacted both older people and minority populations. Clinical research studies often require large numbers of volunteers from diverse populations to participate in a single study. Sometimes thousands of volunteers are needed to obtain reliable information. This helps to ensure that medications, vaccines, and therapeutic antibodies are generally safe and work for different people, especially those most impacted by the disease or illness.

In this study, participants will be randomly assigned (by chance) to receive 2 injections at one time of either the investigational monoclonal antibodies or a placebo (called the study injections). Participants will not know if they receive investigational antibodies or placebo. A placebo looks like the investigational antibodies but contains no active medicine (antibody). There is twice as much chance of receiving the investigational antibodies than of receiving the placebo.

The study is now enrolling volunteers who have an increased risk of getting COVID-19 due to location, employment, or personal circumstances. You may also be interested in the study if you are less likely than most adults to benefit from a vaccine. For example, due to older age, obesity, or immunosuppression from a health condition or medication.

What to expect

You will be in the PROVENT Study about 1 year.
Several tests and assessments will be performed to monitor your health. These will include:

– Questions about your health, any medications you have taken, and how you are feeling

– Measurements of vital signs (blood pressure, heart rate, breathing rate, oxygen saturation, and body temperature)

– Physical examinations

– Electrocardiogram

– Blood tests

– Urine tests

The study periods

The PROVENT Study has a screening period, and a study treatment and follow-up period.

1. Screening

Up to 7 days

You will visit the study centre to see if the study is right for you, learn more about it, and decide whether you want to take part.

2. Study treatment and follow-up

Up to 1 year

You will visit the study centre 7 times for study assessments. You will be given the study injection (investigational monoclonal antibodies or placebo) as 2 injections at a visit at the beginning of the study. You will also receive regular phone calls, emails, or text messages asking if you have any symptoms of COVID-19. If you develop symptoms of COVID-19, you will be given a COVID-19 test and if it is positive, you will be required to return to the study centre for up to 4 additional visits and will need to wear a digital health device for up to 28 days.