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.