Phase 3 Randomized Double-Blind Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2

Brief description of study

The study is researching an experimental drug combination REGN10933 and REGN10987, given as separate subcutaneous (SC, under the skin) injections. REGN10933 and REGN10987 will sometimes be collectively referred to as the “study drugs” in this consent form. The aim of the study is to see how safe, tolerable, and effective the study drugs may be in treating people who have been exposed to SARS CoV-2 by someone with whom you live and have tested negative or positive for SARS-CoV-2 virus but are not showing any signs of infection. The study is trying to answer several specific research questions. These include: whether the study drugs can reduce the likelihood of a person getting the SARS-CoV-2 infection who tested negative or whether the study drugs can prevent the SARS-CoV-2 infection from developing into COVID-19 disease for people who tested positive. Whether the study drugs can help reduce the number days a person is away from work who tested positive or negative to the SARS-CoV-2 virus or whether the study drugs can help reduce the number of visits to the doctor’s office for people who tested positive or negative to the SARS-CoV-2 virus. In addition whether any side effects may happen from taking the study drugs or how much study drugs are in your blood at different times. And whether the body makes its own antibodies against the study drugs (which could make them less effective or could lead to side effects).


Clinical Study Identifier: s20-01435
ClinicalTrials.gov Identifier: NCT04452318


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