Clinical Trials | Outpatient Research Study for Adults (55 or older OR 18 or older with weakened immune system) who tested + for COVID in last = 5 days with no or symptom onset within = 5 days

The Department of Medicine, Division of Infectious Disease seeks adults who have recently tested positive for COVID-19 within the last 5 days for a research study. People early on in their infection who test positive for COVID-19 and have a higher risk of getting very sick will take part in this study. The study team hopes to find out if giving anti-SARS-CoV-2 hyperimmunoglobulin (hIVIG) to people early in their infection with COVID-19, before the body has had a chance to make its own antibodies, can help prevent bad effects from COVID-19 and enable them to stay out of the hospital. You may be eligible for this study if you: ? Are 55 or older OR are 18 or older with a weakened immune system ? Have tested positive for COVID-19 within the past 5 days ? Are not having symptoms OR have symptom onset within = 5 days ? Are not currently hospitalized What is hIVIG? hIVIG stands for “hyperimmune intravenous immunoglobulin.” hIVIG is made from blood plasma donated by healthy people who have recovered from COVID-19 and have been vaccinated against COVID-19. Plasma is the liquid part of your blood. The plasma is collected and purified to make hIVIG. It contains high levels of antibodies that fight the virus that causes COVID-19 (SARS-CoV-2). Antibodies are natural proteins made by the body to fight or prevent infection. If you join this study, you will receive one dose of either hIVIG or a placebo (salt water which has no drug in it). Your chance of receiving hIVIG will be 50%, which is just like flipping a coin. You will get hIVIG or placebo as a drip or infusion (IV) into one of your veins. The study team will watch you while the infusion is being given and for some time after. You will get the usual standard care for COVID-19 that you would receive even if you were not in a study. Your decision to join the study is purely up to you, and you can change your mind at any time. This study lasts for up to 30 days long. Study involves taking an experimental medicine/placebo (Day 0), blood draws, saliva and nose swab samples (Day 0 & 7). On Days 1-7 you will take temperatures at home and measure your oxygen levels every day, and on days 1,4,14 and 28 there will be a 10-minute phone call. Study-related medications, devices, procedures, provided at no cost. Additional information can be found here: Outpatient Treatment With Anti-Coronavirus Immunoglobulin (OTAC) Contact Email: [email protected] Contact Phone: 855-UVA-JEDI (882-5334) Toll-Free or 434-243-4008