Study for healthy people with a drug against Covid-19
In BRG we are currently performing a study for healthy people with a drug against Covid-19 .
In the project we are comparing experimental injectable drug called ADG20 versus a placebo (an injection similar in appearance to ADG20 but containing no active ingredients)
It is expected that this study will involve a maximum of approximately 6,412 participants in approximately 100 research sites around the world. The study will include 2 groups of participants: one group will include approximately 1,270 participants who have recently had contact with a person diagnosed with SARS-CoV-2 infection (group A), and the other group will include approximately 5,142 participants who were not exposed to to SARS-CoV-2, but who are at increased risk of exposure (Group B). Exposure essentially means that a person is within 2 meters (6 feet) of a person with COVID-19 for at least 15 minutes while neither person is wearing a mask.
The study is divided into 2 parts. About 200 adult participants in both groups will be enrolled in Part 1 of this study. Remaining participants, including both adult and adolescent patients, will be enrolled in Part 2 of the study in both groups.
The tested drug is an antibody to SARS-CoV-2 (the virus that causes COVID-19). Antibodies are proteins that help you fight infection and can help protect you from reinfection (this is called immunity). Antibodies are one of your body's ways of fighting infections naturally. Scientists can also make antibodies (such as a study drug) in laboratories and inject them into humans. The study medicine works by acting on a part of the SARS-CoV-2 virus called the 'spike protein', which inactivates the virus. In laboratory studies, ADG20 was associated with all common circulating variants of SARS-CoV-2 known as of March 2021.
The purpose of the study is to evaluate the safety and efficacy of the study drug in adults (aged 18 years and over) and adolescents (aged 12 to 17 years).