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A Study Testing the Safety and Effectiveness of Antibodies for Treating Early Stages of COVID-19 in Non-hospitalized Patients

This study will test whether a single dose of antibodies can help prevent COVID-19 from getting worse in high-risk adult patients recently diagnosed with COVID-19.


Why this Research Matters

If you have been recently diagnosed with COVID-19, we want to find out if a single dose of antibodies can help prevent your disease from getting worse as compared to a placebo. Antibodies are protective proteins made by the immune system. A placebo is an inactive product that looks the same and is given the same way as the antibody treatment. The placebo for this study is normal saline, which is similar to the balance of water and salt already present in blood in the human body. You will be randomly assigned to receive either the antibody treatment or the placebo. Random assignment means that what treatment you receive is by chance, like flipping a coin. You and the study staff will not know what treatment you received. We are focusing on higher-risk patients whose immune systems may not be able to fight the virus very well. A nurse will collect baseline data, blood, saliva and a nasal swab before the treatment is given. Seven days after the treatment, a mobile lab will visit your home to collect additional blood, saliva and nasal swabs samples. The research team will call to check in on you at 5 different timepoints through 28 days after your treatment.


Who can Participate

Adult

You may be eligible for the study: if you are at least 55 years old, or at least 18 years old with a weakened immune system; if you have been diagnosed with COVID-19 within the last 5 days; if you have COVID-19 symptoms and they have started within the last 5 days. You may not be eligible for the study: if you have any condition that increases the risk of blood clots or other serious problems with blood; if you have a history of allergic reactions to blood products or treatments like the one being studied; if you have certain immune system issues such as IgA deficiency; if you have pneumonia or difficulty breathing due to COVID-19; if you need to be admitted to the hospital; if you have received an antibody treatment or another similar treatment for COVID-19 in the past 3 months.


Study ID

Protocol Number: 24-0980

Meet the Team

Image of Principal Investigator

Adit Ginde, MD

Principal Investigator


Locations